UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
FOR THE
QUARTERLY PERIOD ENDED JUNE 30, 2009
OR
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
Transition Period from __________________ to
_________________________
Commission
File Number 0-10909
NEOSTEM,
INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
22-2343568
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
|
|
420
LEXINGTON AVE, SUITE 450 NEW YORK, NEW
YORK
|
10170
|
(Address
of principal executive offices)
|
(zip
code)
|
Registrant’s
telephone number, including area code: 212-584-4180
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes o No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer o
|
|
|
Non-accelerated
filer o (Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No x
8,541,848 SHARES,
$.001 PAR VALUE, AS OF AUGUST 12, 2009
(Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date)
INDEX
|
|
Page No.
|
Part
I - Financial Information:
|
|
|
|
|
Item
1.
|
Consolidated
Financial Statements (Unaudited):
|
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
At
June 30, 2009 and December 31, 2008
|
3
|
|
|
|
|
Consolidated
Statements of Operations
|
|
|
for
the three months and six months
|
|
|
ended
June 30, 2009 and 2008
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
|
|
for
the six months ended
|
5
|
|
June
30, 2009 and 2008
|
|
|
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6-22
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
23-32
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About
|
|
|
Market
Risk
|
32
|
|
|
|
Item
4.
|
Controls
and Procedures
|
32-33
|
|
|
|
Part
II - Other Information:
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
33
|
|
|
|
Item
1A.
|
Risk
Factors
|
33
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
|
|
|
Proceeds
|
33-34
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
34
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Securityholders
|
34-35
|
|
|
|
Item
5.
|
Other
Information
|
35
|
|
|
|
Item
6.
|
Exhibits
|
36-37
|
|
|
|
|
Signatures
|
38
|
PART
I. FINANCIAL INFORMATION
Item
1. Consolidated Financial Statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
|
|
June 30,
2009
|
|
|
December 31,
2008
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
10,449,531 |
|
|
$ |
430,786 |
|
Accounts
receivable
|
|
|
39,008 |
|
|
|
7,193 |
|
Receivable
due from related party
|
|
|
375,000 |
|
|
|
- |
|
Prepaid
expenses and other current assets
|
|
|
91,447 |
|
|
|
92,444 |
|
Total
current assets
|
|
|
10,954,986 |
|
|
|
530,423 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
138,637 |
|
|
|
99,490 |
|
Goodwill
|
|
|
558,169 |
|
|
|
558,169 |
|
Intangible
Asset
|
|
|
616,184 |
|
|
|
633,789 |
|
Other
assets
|
|
|
156,568 |
|
|
|
2,445 |
|
|
|
$ |
12,424,544 |
|
|
$ |
1,824,316 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
167,594 |
|
|
$ |
508,798 |
|
Accrued
liabilities
|
|
|
360,845 |
|
|
|
427,767 |
|
Notes
payable
|
|
|
38,798 |
|
|
|
- |
|
Unearned
revenues
|
|
|
122,406 |
|
|
|
9,849 |
|
Dividends
Payable
|
|
|
251,727 |
|
|
|
- |
|
Capitalized
lease obligations – current portion
|
|
|
2,600
|
|
|
|
14,726 |
|
Total
current liabilities
|
|
|
943,970 |
|
|
|
961,140 |
|
Total
liabilities |
|
|
943,970 |
|
|
|
961,140 |
|
|
|
|
|
|
|
|
|
|
Convertible
Redeemable Series D Preferred stock; liquidation value $12.50 per share;
1,293,251 shares issued and outstanding
|
|
|
7,685,768 |
|
|
|
- |
|
Stockholders’
Equity:
|
|
|
|
|
|
|
|
|
Preferred
stock; authorized, 5,000,000 shares
|
|
|
|
|
|
|
|
|
Series
B convertible redeemable preferred stock,
|
|
|
|
|
|
|
|
|
liquidation
value 10 shares of common stock per share; $0.01 par value; authorized,
825,000 shares; issued and outstanding, 10,000 shares
|
|
|
100 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
Common
stock, $.001 par value; authorized,
|
|
|
|
|
|
|
|
|
500,000,000
shares; issued and outstanding,
|
|
|
|
|
|
|
|
|
8,007,705
June 30, 2009 and
|
|
|
|
|
|
|
|
|
7,715,006
December 31, 2008
|
|
|
8,007 |
|
|
|
7,715 |
|
Additional
paid-in capital
|
|
|
50,591,405 |
|
|
|
40,849,670 |
|
Accumulated
deficit
|
|
|
(46,804,644 |
) |
|
|
(39,994,309
|
) |
Accumulated
other comprehensive loss
|
|
|
(62 |
) |
|
|
- |
|
Total
stockholders’ equity
|
|
|
3,794,806 |
|
|
|
863,176 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
12,424,544 |
|
|
$ |
1,824,316 |
|
See
accompanying notes to consolidated financial statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
See
accompanying notes to consolidated financial statements
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Earned
revenues
|
|
$ |
31,600 |
|
|
$ |
23,528 |
|
|
$ |
76,738 |
|
|
$ |
24,221 |
|
Direct
costs
|
|
|
15,750 |
|
|
|
3,908 |
|
|
|
39,300 |
|
|
|
3,908 |
|
Gross
profit
|
|
|
15,850 |
|
|
|
19,620 |
|
|
|
37,438 |
|
|
|
20,313 |
|
Selling,
general, administrative and research
|
|
|
4,715,167 |
|
|
|
2,379,387 |
|
|
|
6,593,704 |
|
|
|
4,903,718 |
|
Operating
loss
|
|
|
(4,699,317 |
) |
|
|
(2,359,767 |
) |
|
|
(6,556,266 |
) |
|
|
(4,883,405 |
) |
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
12,389 |
|
|
|
1,712 |
|
|
|
12,694 |
|
|
|
1,712 |
|
Interest
expense
|
|
|
(4,437 |
) |
|
|
(3,718 |
) |
|
|
(15,036 |
) |
|
|
(7,269 |
) |
Net
loss
|
|
|
(4,691,365 |
) |
|
|
(2,361,773 |
) |
|
|
(6,558,608 |
) |
|
|
(4,888,962 |
) |
Dividends
Series D Preferred Stock
|
|
|
(251,727 |
) |
|
|
- |
|
|
|
(251,727 |
) |
|
|
- |
|
Net
loss attributable to Common Shareholders
|
|
$ |
(4,943,092 |
) |
|
$ |
(2,361,773 |
) |
|
$ |
(6,810,335 |
) |
|
$ |
(4,888,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share
|
|
$ |
(0.62 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.94 |
) |
Weighted
average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
common
shares outstanding
|
|
|
7,970,469 |
|
|
|
5,490,257 |
|
|
|
7,887,318 |
|
|
|
5,196,717 |
|
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Six Months Ended
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(6,810,335)
|
|
|
$ |
(4,888,962)
|
|
Adjustments to reconcile net
loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Common
shares issued and stock options granted for services
rendered
|
|
|
1,758,574
|
|
|
|
2,407,961
|
|
Depreciation
and amortization
|
|
|
60,009
|
|
|
|
41,462
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(31,816)
|
|
|
|
(6,525)
|
|
Prepaid
expenses and other assets
|
|
|
(153,794)
|
|
|
|
(59,872)
|
|
Unearned
revenues
|
|
|
112,557
|
|
|
|
(233)
|
|
Accounts
payable, accrued expenses, and other current liabilities
|
|
|
(156,395)
|
|
|
|
(191,967)
|
|
Net
cash used in operating activities
|
|
|
(5,221,200)
|
|
|
|
(2,698,136)
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Acquisition
of equipment
|
|
|
(80,947)
|
|
|
|
(2,379)
|
|
Net
cash used in investing activities
|
|
|
(80,947)
|
|
|
|
(2,379)
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
Proceeds from issuance of convertible redeemable preferred stock and
warrants
|
|
|
15,669,220
|
|
|
|
-
|
|
Amounts
due from a related party
|
|
|
(375,000)
|
|
|
|
-
|
|
Net
Proceeds from issuance of Common Stock
|
|
|
-
|
|
|
|
896,760
|
|
Proceeds
from advances on notes payable
|
|
|
1,284,753
|
|
|
|
131,618
|
|
Payments
of capitalized lease obligations
|
|
|
(12,126
|
)
|
|
|
(12,072)
|
|
Repayments
of notes payable
|
|
|
(1,245,955)
|
|
|
|
(90,923)
|
|
Net
cash provided by financing activities
|
|
|
15,320,892
|
|
|
|
925,383
|
|
Net
increase/(decrease) in cash and cash equivalents
|
|
|
10,018,745
|
|
|
|
(1,775,132)
|
|
Cash
and cash equivalents at beginning of period
|
|
|
430,786
|
|
|
|
2,304,227
|
|
Cash
and cash equivalents at end of period
|
|
$ |
10,449,531
|
|
|
$ |
529,095
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2009
|
|
|
2008
|
|
Supplemental Disclosure
of Cash Flow Information:
|
|
|
|
|
|
|
Cash
paid during the period for:
|
|
|
|
|
|
|
Interest
|
|
$ |
15,036
|
|
|
$ |
7,269
|
|
Supplemental
Schedule of Non-cash Financing Activities:
|
|
|
|
|
|
|
|
|
Issuance
of restricted common stock for services
|
|
|
104,850
|
|
|
|
-
|
|
Issuance
of common stock for services rendered
|
|
|
198,055
|
|
|
|
476,842
|
|
Issuance
of common stock for compensation
|
|
|
-
|
|
|
|
66,515
|
|
Issuance
of warrants for services
|
|
|
76,215
|
|
|
|
109,958
|
|
Issuance
of common stock for payment of debt
|
|
|
-
|
|
|
|
5,647
|
|
Compensatory
element of stock options
|
|
|
1,398,387
|
|
|
|
1,202,223
|
|
Vesting
of restricted common stock during period
|
|
|
85,917
|
|
|
|
546,776
|
|
See
accompanying notes to consolidated financial statements.
NEOSTEM,
INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED
FINANCIAL STATEMENTS
Note 1 - The
Company
NeoStem,
Inc. (“NeoStem” or the “Company”) was incorporated under the laws of
the State of Delaware in September 1980 under the name Fidelity Medical
Services, Inc. Our corporate headquarters is located at 420 Lexington
Avenue, Suite 450, New York, NY 10170, our telephone number is (212) 584-4180
and our website address is www.neostem.com.
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors which can then be accessed for their own future medical
treatment. As part of our adult stem cell banking business we have
developed a network of adult stem cell collection centers in major metropolitan
areas of the United States. The terms of NeoStem’s collection center
agreements are substantially similar. NeoStem provides adult stem cell
processing and storage services, as well as expertise and certain business,
management and administrative services of a non-clinical nature in connection
with the delivery of stem cell collection services, to each collection center.
In each case, the collection center agrees that NeoStem will be the exclusive
provider to it of adult stem cell processing and storage, management and other
specified services. The agreements generally provide for the payment to NeoStem
by the collection center of specified marketing and support fees and annual
network services fees, and provide a fee schedule and the allocation of expenses
and revenues among the parties. NeoStem does not have any equity or other
financial interests in any of the collection centers. Each of the
agreements is for a multi-year period, depending on the particular center,
typically has an automatic renewal for consecutive one year periods at the end
of the initial term and may relate to a territory. The agreements contain
insurance obligations and indemnification provisions, limitations on liability
and other standard provisions. NeoStem grants to each collection center a
non-exclusive license to use its trademarks and intellectual property but
otherwise retains all rights thereto, and each collection center is bound by
confidentiality obligations to NeoStem and non-competition provisions. The
agreements may be terminated upon prior written notice a specified period in
advance upon certain uncured material breaches of the agreement or, depending on
the agreement, certain other specified occurrences.
We have
also entered the research and development arenas, through the acquisition of a
worldwide exclusive license to an early-stage technology to identify and isolate
rare stem cells from adult human bone marrow, called VSEL (very small
embryonic-like) stem cells. VSELs have many physical characteristics typically
found in embryonic stem cells, including the ability to differentiate into
specialized cells found in substantially all the different types of cells and
tissue that make up the body.
On
January 19, 2006, we consummated the acquisition of the assets of NS California,
Inc., a California corporation (“NS California”) relating to NS California’s
business of collecting and storing adult stem cells. Effective with the
acquisition, the business of NS California became our principal business, rather
than our historic business of providing capital and business guidance to
companies in the healthcare and life science industries. The Company
provides adult stem cell processing, collection and banking services with the
goal of making stem cell collection and storage widely available, so that the
general population will have the opportunity to store their own stem cells for
future healthcare needs. The Company is also pursuing other technologies to
advance its position in the field of stem cell tissue regeneration.
In
connection with carrying out its expansion objectives in the People’s Republic
of China (“PRC”), NeoStem has recently established a wholly foreign owned
subsidiary in China, known as NeoStem (China), Inc. (“WFOE” or “NeoStem China”).
The WFOE is domiciled in Qingdao and under its scope of business approved by the
Chinese regulatory authorities, the WFOE may engage in the research &
development, transfer and technological consultation service of bio-technology,
regenerative medical technology and anti-aging technology (excluding the
development or application of human stem cell, gene diagnosis and treatment
technologies); consultation of economic information; import, export and
wholesaling of machinery and equipments (the import and export do not involve
the goods specifically stipulated in/by state-operated trade, import &
export quota license, export quota bidding, export permit, etc.). At June 30,
2009 we have capitalized the WFOE in an initial amount of approximately
$1,000,000 and subsequently on July 2, 2009 we have invested an additional
$1,900,000 to increase the capitalization of NeoStem China. In furtherance of
complying with PRC’s foreign investment prohibition on stem cell research and
development, clinical trials and related activities, we conduct our current
business in the PRC via the following two domestic variable interest entities
(“VIEs”):
Qingdao
Niao Bio-Technology Ltd. (“Qingdao Niao”) is a Chinese domestic company
controlled by the WFOE through various business agreements. Under its scope of
business approved by the registration authorities, Qingdao Niao may engage in
research and development in, transfer of and technical consultation in bio-cell
technology, gene technology and regenerative medical technology. Qingdao Niao is
wholly owned by a PRC national who is also Qingdao Niao’s Legal Representative
and Executive Director. At June 30, 2009 we have capitalized this VIE with an
initial amount of approximately $176,000.
Beijing
Ruijiao Bio-Technology Ltd. (“Beijing Ruijiao”) is a Chinese domestic company
controlled by the WFOE through various business agreements. Under its scope of
business approved by the registration authorities, Beijing Ruijiao may engage in
technology development, technology transfer, technology consultation and
technology services. Beijing Ruijiao is wholly owned by a PRC national who is
also Beijing Ruijiao’s Legal Representative and Executive Director. The main
activity of Beijing Ruijiao is to establish an R&D lab in Beijing and to act
as one of the sharing beneficiaries of any potential financial benefits
generated from commercialization of successful clinical trials conducted jointly
from collaborations between the lab and partner hospitals. At June 30, 2009 we
had not capitalized this VIE.
The
capital investment in these VIEs is funded by NeoStem through the WFOE and
recorded as interest-free loans to the shareholders of Qingdao Niao and Beijing
Ruijiao. As of June 30, 2009 approximately $176,000 has been loaned to the
shareholder of Qingdao Niao to capitalize Qingdao Niao and as of July 2, 2009,
the total amount of interest free loans to these shareholders of the VIEs listed
above was approximately $300,000.
According
to the current PRC regulation, the development and application of human stem
cell technology are placed in the “prohibited” category, off limits to foreign
investors. This policy prohibition precludes NeoStem from participating directly
in stem cell related business in China. NeoStem does not have direct ownership
interests in either Qingdao Niao or Beijing Ruijiao. Under various contractual
agreements, the shareholders of the VIEs are required to transfer their
ownership interests in these entities to the WFOE in China in the event Chinese
laws and regulations allow foreign investors to hold ownership interests in the
VIEs, or to our designees at any time for the amount of, to the extent permitted
by Chinese laws, outstanding loans. The shareholders of the VIEs have entrusted
us to appoint the directors and senior management personnel of the VIEs on their
behalf. Through the WFOE, we have entered into exclusive technical and
management service agreements with the VIEs, under which the WFOE is providing
technical and management services to the VIEs in exchange for substantially all
net income of the VIEs. In addition, shareholders of the VIEs have pledged their
equity interests in the VIEs to the WFOE as collateral for non-payment of loans
or for fees on technical and management services due to us, which equity pledge
agreements are now required to be registered with the relevant administration of
industry and commerce to make the equity pledges become effective.
In
November 2008 (amended in July 2009), the Company entered into an Agreement and
Plan of Merger (the “Merger Agreement”) with China BioPharmaceuticals Holdings,
Inc. (“CBH”), pursuant to which (subject to shareholder approval and certain
other conditions) CBH will be merged with and into a wholly-owned subsidiary of
the Company (the “Merger”). The Merger Agreement provides that, among
other things, at the effective time of the Merger, the only material assets of
CBH will be CBH’s 51% interest in Suzhou Erye Pharmaceuticals Company Ltd.
(“Erye”), a Sino-foreign joint venture with limited liability organized under
the laws of the PRC, and at least $550,000 in cash. Erye specializes in
research and development, production and sales of pharmaceutical products, as
well as chemicals used in pharmaceutical products. Erye, which has been in
business for more than 50 years, currently manufactures over 100 drugs on seven
Good Manufacturing Practices (GMP) lines, including small molecule
drugs.
On August
9, 2007, the Company’s Common Stock commenced trading on the American Stock
Exchange (now NYSE Amex) under the symbol “NBS.”
Note 2 - Summary of
Significant Accounting Policies
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America for interim financial information and with the instructions for Form
10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by accounting principles generally
accepted in the United States of America for complete financial statements. In
the opinion of management, the statements contain all adjustments (consisting
only of normal recurring accruals) necessary to present fairly the financial
position as of June 30, 2009 and December 31, 2008, the results of operations
for the three and six months ended June 30, 2009 and 2008 and the cash flows for
the three and six months ended June 30, 2009 and 2008. The results of
operations for the three and six months ended June 30, 2009 are not necessarily
indicative of the results to be expected for the full year.
The
December 31, 2008 consolidated balance sheet has been derived from the audited
consolidated financial statements at that date included in the Company's Annual
Report on Form 10-K. These unaudited consolidated financial statements should be
read in conjunction with the consolidated financial statements and notes thereto
included in the Company's Annual Report on Form 10-K.
Principles of Consolidation:
The consolidated financial statements include the accounts of NeoStem, Inc. (a
Delaware corporation) and its wholly-owned subsidiaries, NeoStem Therapies,
Inc., Stem Cell Technologies, Inc. and NeoStem (China) Inc. and its variable
interest entities, Qingdao Niao Bio-Technology Ltd and Beijing Ruijiao
Bio-Technology Ltd. All intercompany transactions and balances have been
eliminated
Use of Estimates: The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts and disclosures.
Accordingly, actual results could differ from those estimates.
Cash Equivalents: Short-term
cash investments, which have a maturity of ninety days or less when purchased,
are considered cash equivalents in the consolidated statement of cash
flows.
Concentrations of
Credit-Risk: Financial instruments that potentially subject the Company
to significant concentrations of credit risk consist principally of cash. The
Company places its cash accounts with high credit quality financial
institutions, which at times may be in excess of the FDIC insurance
limit.
Allowance for Doubtful Accounts:
The Company establishes an allowance for doubtful accounts to provide for
accounts receivable that may not be collectible. In establishing the allowance
for doubtful accounts, the Company analyzes the collectability of individual
large or past due accounts customer-by-customer and establishes reserves for
accounts that it determines to be doubtful of collection. There was no allowance
for doubtful accounts necessary at June 30, 2009 and December 31,
2008.
Property and Equipment: The
cost of property and equipment is depreciated over the estimated useful lives of
the related assets of 3 to 5 years. The cost of computer software programs are
amortized over their estimated useful lives of five years. Depreciation is
computed on the straight-line method. Repairs and maintenance expenditures that
do not extend original asset lives are charged to expense as
incurred.
Income Taxes: The Company, in
accordance with SFAS 109, “Accounting for Income Taxes,” recognizes (a) the
amount of taxes payable or refundable for the current year and (b) deferred tax
liabilities and assets for the future tax consequences of events that have been
recognized in an enterprise’s financial statement or tax returns.
Comprehensive Income (Loss):
Refers to revenue, expenses, gains and losses that under generally
accepted accounting principles are included in comprehensive income but are
excluded from net income as these amounts are recorded directly as an adjustment
to stockholders’ equity. At December 31, 2008 there were no such
adjustments required. At June 30, 2009 a $62 exchange rate loss was recognized
which has been reflected on the balance sheet as accumulated other comprehensive
loss as a separate component of stockholder’s equity, in accordance with the
consolidation of a foreign operation.
Goodwill: Goodwill represents
the excess of the purchase price over the fair value of the net assets acquired
in a business combination. The Company reviews recorded goodwill for potential
impairment annually or upon the occurrence of an impairment indicator. The
Company performed its annual impairment tests as of December 31, 2008 and
determined no impairment exists. The Company will perform its future annual
impairment as of the end of each fiscal year.
Intangible Asset: SFAS No.
142 requires purchased intangible assets other than goodwill to be amortized
over their useful lives unless those lives are determined to be indefinite.
Purchased intangible assets are carried at cost less accumulated amortization.
Definite-lived intangible assets, which consists of patents and rights
associated with the Very Small Embryonic Like (“VSEL”) Stem Cells which
constitutes the principal assets acquired in the acquisition of Stem Cell
Technologies, Inc., have been assigned a useful life and are amortized on a
straight-line basis over a period of twenty years.
Impairment of Long-lived
Assets: We
review long-lived assets and certain identifiable intangibles to be held and
used for impairment on an annual basis and whenever events or changes in
circumstances indicate that the carrying amount of an asset exceeds the fair
value of the asset. If other events or changes in circumstances indicate that
the carrying amount of an asset that we expect to hold and use may not be
recoverable, we will estimate the undiscounted future cash flows expected to
result from the use of the asset or its eventual disposition, and recognize an
impairment loss. The impairment loss, if determined to be necessary, would be
measured as the amount by which the carrying amount of the assets exceeds the
fair value of the assets.
Accounting for Stock Based
Compensation: In December 2004, the FASB issued SFAS No. 123(R),
"Share-Based Payment" ("SFAS No. 123(R)"). SFAS No. 123(R) establishes standards
for the accounting for transactions in which an entity exchanges its equity
instruments for goods or services. This statement focuses primarily on
accounting for transactions in which an entity obtains employee services in
share-based payment transactions. SFAS No. 123(R) requires that the fair value
of such equity instruments be recognized as an expense in the historical
financial statements as services are performed. Prior to SFAS No. 123(R), only
certain pro forma disclosures of fair value were required. The Company has
adopted SFAS No. l23(R) effective January 1, 2006. The Company determines value
of stock options by the Black-Scholes option pricing model. The value of options
issued since January 1, 2006 or that were unvested at January 1, 2006 are being
recognized as an operating expense ratably on a monthly basis over the vesting
period of each option. With regard to stock options and warrants issued to
non-employees the Company has adopted EITF 96-18 “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring or in
Conjunction with Selling Goods and Services.”
Earnings Per Share: Basic
(loss)/earnings per share is based on the weighted effect of all common shares
issued and outstanding, and is calculated by dividing net (loss)/income
available to common stockholders by the weighted average shares outstanding
during the period. Diluted (loss)/earnings per share, which is calculated by
dividing net (loss)/income available to common stockholders by the weighted
average number of common shares used in the basic earnings per share calculation
plus the number of common shares that would be issued assuming conversion of all
potentially dilutive securities outstanding, is not presented as it is
anti-dilutive in all periods presented. For the three and six months
ended June 30, 2009 and 2008 the Company incurred net losses and therefore no
common stock equivalents were utilized in the calculation of earnings per share.
At June 30, 2009 and 2008 the Company had common stock equivalents outstanding
as follows:
|
|
June 30,
2009
|
|
|
June 30,
2008
|
|
Stock
Options
|
|
|
2,565,800
|
|
|
|
1,779,800
|
|
Warrants
|
|
|
18,262,204
|
|
|
|
3,173,397
|
|
Series
D Stock, Common stock equivalents
|
|
|
12,932,510
|
|
|
|
-
|
|
Advertising Policy: All
expenditures for advertising are charged against operations as
incurred.
Revenue Recognition: The
Company initiated the collection and banking of autologous adult stem cells in
the fourth quarter of 2006. The Company recognizes revenue related to the
collection and cryopreservation of autologous adult stem cells when the
cryopreservation process is completed which is generally twenty four hours after
cells have been collected. Revenue related to advance payments of storage fees
is recognized ratably over the period covered by the advanced payments. The
Company also earns revenue, in the form of start up fees, from physicians
seeking to establish autologous adult stem cell collection centers. Start up
fees are billed once the agreement has been signed and the physician has been
qualified by the Company’s credentialing committee. During the quarter ended
June 30, 2009, the Company has modified its revenue recognition policy relative
to these fees to recognize such fees as revenues ratably over the appropriate
period of time to which the revenue element relates. Previously these fees were
recognized in full when agreements were signed and the physician had been
qualified by the Company’s credentialing committee. This modification of our
revenue recognition policy did not have a material impact on our results of
operations.
Note 3 – Recent Accounting
Pronouncements
In June
2008, FASB ratified EITF No. 07-5, "Determining Whether an Instrument
(or an Embedded Feature) Is Indexed to an Entity's Own Stock" ("EITF
07-5"). EITF 07-5 provides that an entity should use a two-step approach to
evaluate whether an equity-linked financial instrument (or embedded feature) is
indexed to its own stock, including evaluating the instrument's contingent
exercise and settlement provisions. EITF 07-5 is effective for financial
statements issued for fiscal years beginning after December 15, 2008. Early
application is not permitted. At the present time we do not have any such equity
instruments but we are assessing the potential impact of this EITF on our future
financial condition and results of operations.
In April
2009, the FASB issued FASB Staff Position No. 141(R)-1, Accounting for Assets Acquired and
Liabilities Assumed in a Business Combination That Arise from
Contingencies, (“FSP 141(R)-1”). FSP 141(R)-1 amends and clarifies SFAS
No. 141(R). FSP 141(R)-1 requires an acquirer to recognize at fair value, at the
acquisition date, an asset acquired or a liability assumed in a business
combination that arises from a contingency if the acquisition-date fair value of
that asset or liability can be determined during the measurement period. If the
fair value cannot be determined during the measurement period, an asset or a
liability shall be recognized at the acquisition date if the asset or liability
can be reasonably estimated and if information available before the end of the
measurement period indicates that it is probable that an asset existed or that a
liability had been incurred at the acquisition date. FSP 141(R)-1 amends the
disclosure requirements of SFAS No. 141(R) to include business combinations that
occur either during the current reporting period or after the reporting period
but before the financial statements are issued. FSP 141(R)-1 is effective for
fiscal years beginning after December 15, 2008 and interim periods within those
years. We are currently evaluating the requirements of this pronouncement
as it relates to our proposed merger with China Biopharmaceuticals Holdings,
Inc. but do not anticipate this will have an impact on our financial position or
our consolidated financial statements post-merger. This statement was effective
January 1, 2009.
In
December 2008, the FASB issued FASB Staff Position (“FSP”) FAS 140-4 and FIN
46(R)-8, Disclosures by Public
Entities (Enterprises) about Transfers of Financial Assets and Interests in
Variable Interest Entities. This document increases disclosure
requirements for public companies and is effective for reporting periods
(interim and annual) that end after December 15, 2008. The purpose of this FSP
is to promptly improve disclosures by public entities and enterprises until the
pending amendments to FASB Statement No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities, and
FASB Interpretation No. 46 (revised December 2003), Consolidation of Variable Interest
Entities, are finalized and approved by the Board. The FSP amends
Statement 140 to require public entities to provide additional disclosures about
transferors’ continuing involvements with transferred financial assets. It also
amends Interpretation 46(R) to require public enterprises, including sponsors
that have a variable interest in a variable interest entity, to provide
additional disclosures about their involvement with variable interest entities.
We implemented the requirements of FSP FAS 140-4 and FIN 46(R)-8 in the second
quarter of 2009. As the requirements of this literature only impact our
disclosures, there was no impact to our financial results.
In April
2009, the FASB issued FASB Staff Position No. 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly , (“FSP
157-4”). FSP 157-4 provides additional guidance for estimating fair value in
accordance with SFAS No. 157 when the volume and level of activity for the asset
or liability have significantly decreased. FSP 157-4 also includes guidance on
identifying circumstances that indicate a transaction is not orderly. FSP 157-4
requires the disclosure of the inputs and valuation technique used to measure
fair value and a discussion of changes in valuation techniques and related
inputs, if any, during the period. FSP 157-4 also requires that the entity
define major categories for equity securities and debt securities to be major
security types. FSP 157-4 is effective for interim and annual reporting periods
ending after June 15, 2009. We have adopted FSP 157-4 in our quarter ended June
30, 2009. The adoption of FASB Staff Position No. 157-4 did not have a material
impact on our financial position or results of operations.
In April
2009, the FASB issued FASB Staff Position No. 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments, (“FSP 115-2 and FSP 124-2”). This FSP
amends the other-than-temporary impairment guidance in U.S. GAAP for debt
securities to make the guidance more operational and to improve the presentation
and disclosure of other-than-temporary impairments on debt and equity securities
in the financial statements. This FSP does not amend existing recognition and
measurement guidance related to other-than-temporary impairments of equity
securities. FSP 115-2 and 124-2 requires the entity to assess whether the
impairment is other-than-temporary if the fair value of a debt security is less
than its amortized cost basis at the balance sheet date. This statement also
provides guidance to assessing whether or not the impairment is
other-than-temporary and guidance on determining the amount of the
other-than-temporary impairment that should be recognized in earnings and other
comprehensive income. FSP 115-2 and 124-2 also requires an entity to disclose
information that enables users to understand the types of securities held,
including those investments in an unrealized loss position for which the
other-than-temporary impairment has or has not been recognized. FSP 115-2 and
124-2 are effective for interim and annual reporting periods ending after June
15, 2009. The adoption of FASB Staff Position No. 115-2 and FAS 124-2 did not
have a material impact on our financial position or results of
operations.
In April
2009, the FASB issued FASB Staff Position No. FAS 107-1 and APB 28-1,
Interim Disclosures about Fair
Value of Financial Instruments. This Staff Position amends FASB Statement
No. 107, Disclosures
about Fair Value of Financial Instruments, to require disclosures about
fair value of financial instruments at interim reporting periods. This Staff
Position is effective for interim reporting periods ending after June 15,
2009, with early adoption permitted for periods ending after March 15, 2009
provided FSP No. FAS 115-2 and FAS 124-2 (described above) are
also early adopted. We adopted FSP No. FAS 107-1 in our quarter ended
June 30, 2009. The adoption of FASB Staff Position No. FAS 107-1 and APB
28-1 did not have a material impact on our financial position or results of
operations.
In May
2009, the FASB issued Statement No. 165, Subsequent Events. Statement
165 establishes general standards of accounting for and disclosure of
events that occur after the balance sheet date but before the financial
statements are issued or are available to be issued. We have adopted Statement
165 in our quarter ended June 30, 2009. The adoption of Statement No. 165
did not have a material impact on our financial position or results of
operations.
In June
2009, the FASB issued Statement No. 166, Accounting for Transfers of
Financial Assets, an amendment of FASB Statement No. 140. Statement
166 eliminates the concept of a “qualifying special-purpose entity” from
Statement 140 and changes the requirements for derecognizing financial assets.
We will adopt Statement 166 in 2010 and are currently evaluating the impact of
its pending adoption on our consolidated financial statements.
In June
2009, the FASB issued Statement No. 167, Amendments to FASB Interpretation
No. 46(R) . Statement 167 amends the evaluation criteria to identify
the primary beneficiary of a variable interest entity provided by FASB
Interpretation No. 46(R) , Consolidation of Variable Interest
Entities—An Interpretation of ARB No. 51 . Additionally, Statement
167 requires ongoing reassessments of whether an enterprise is the primary
beneficiary of the variable interest entity. We will adopt Statement 167 in 2010
and are currently evaluating the impact of its pending adoption on our
consolidated financial statements.
In
June 2009, the FASB approved the “FASB Accounting Standards Codification”
(“Codification”) as the single source of authoritative nongovernmental U.S. GAAP
to be launched on July 1, 2009. The Codification does not change current
U.S. GAAP, but is intended to simplify user access to all authoritative U.S.
GAAP by providing all the authoritative literature related to a particular topic
in one place. All existing accounting standard documents will be superseded and
all other accounting literature not included in the Codification will be
considered nonauthoritative. The Codification is effective for interim and
annual periods ending after September 15, 2009. The Codification is
effective for us during our interim period ending September 30, 2009 and
will not have an impact on our financial condition or results of operations. We
are currently evaluating the impact to our financial reporting process of
providing Codification references in our public filings.
Note 4 - Notes
Payable
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed merger (the “Merger”) with China
Biopharmaceuticals Holdings, Inc., proposed share exchange (the “Share
Exchange”) relating to the Shandong New Medicine Research Institute of
Integrated Traditional and Western Medicine Limited Liability Company
(“Shandong”), other initiatives in China as well as other ongoing obligations of
the Company, on February 25, 2009 and March 6, 2009, respectively, the Company
issued promissory notes to RimAsia Capital Partners,L.P. (“RimAsia”), a
principal stockholder of the Company, in the principal amounts of $400,000 and
$750,000, respectively. The notes bore interest at the rate of 10%
per annum and were due and payable on October 31, 2009, except that all
principal and accrued interest on the Notes was immediately due and payable in
the event the Company raised over $10 million in equity financing prior to
October 31, 2009. The notes contained standard events of default and
in the event of a default that was not subsequently cured or waived, the
interest rate would increase to a rate of 15% per annum and, at the option of
RimAsia and upon notice, the entire unpaid principal balance together with all
accrued interest thereon would be immediately due and payable. The
notes or any portion thereof could be prepaid at any time and from time to time
at the discretion of the Company without premium or penalty. On April 9, 2009
these notes and the related accrued interest were repaid from the proceeds of an
$11 million offering of units consisting of shares of the Company’s Series D
Convertible Redeemable Preferred Stock and warrants to purchase shares of Common
Stock.
.
The
Company has financed certain insurance polices and has notes payable at June 30,
2009 in the amount of $38,798 related to these policies. These notes require
monthly payments and mature in less than one year.
Note 5 – Convertible
Redeemable Preferred Stock
In April
2009, the Company completed a private placement financing totaling $11 million
(the “April 2009 Private Placement”). This financing consisted of the
issuance of 880,000 units priced at $12.50 per unit, with each unit (the “Series
D Units”) consisting of one share of the Company’s Series D Convertible
Redeemable Preferred Stock (the “Series D Stock”) and ten warrants with each
warrant to purchase one share of Common Stock (the “Series D Warrants”). A total
of 880,000 shares of Series D Stock and 8,800,000 Series D Warrants were
issued. In June 2009, with a final closing on July 6, 2009, the Company
completed an additional private placement financing totaling approximately $5
million with net proceeds of $4,679,220 (the “June 2009 Private
Placement”). This financing consisted of the issuance of 400,280
Series D Units priced at $12.50 per unit, and a total of 400,280 shares of
Series D Stock and 4,002,800 Series D Warrants were issued. The Company paid
$324,280 in fees and issued 12,971 Series D Units to agents that facilitated the
June 2009 Private Placement. The Series D Units issued to the selling agents
were comprised of 12,971 shares of the Series D Stock and 129,712 Series D
Warrants. Upon the affirmative vote of holders of a majority of the voting power
of the Company’s Common Stock required pursuant to the Company’s Amended and
Restated By-Laws and the NYSE Amex, each share of Series D Stock will
automatically be converted into ten (10) shares of Common Stock at an initial
conversion price of $1.25 per share based on an original issue price of $12.50
per share; provided that if by October 31, 2009 such affirmative vote is not
achieved, the Company must redeem all shares of Series D Stock at a redemption
price per share of $12.50 plus the accrued dividends as of such
date. The total cash required to redeem the Series D Stock is
$16,165,638 plus accrued dividends. The Series D Stock has an
accruing dividend of ten percent (10%) per annum, payable (i) annually in cash
on April 9th, provided that the shares of Series D Stock remain outstanding on
such date or (ii) upon a liquidation, dissolution or winding up of the
Company. The Series D Stock (i) ranks senior to all of the Company’s
capital stock with respect to the payment of dividends and to the distribution
of assets upon liquidation, dissolution or winding up, (ii) does not have any
voting rights, (iii) does not have any anti-dilution protection other than
standard protection for stock splits and combinations, and (iv) does not have
any preemptive rights. By June 30, 2009 the Company had
received $4,304,220 of the net proceeds from the June 2009 Private Placement and
the balance of $375,000 was received on July 6, 2009. The Company has accounted
for the issuance of all Series D Stock and Series D Warrants in the June 2009
Private Placement as of June 30, 2009, and the $375,000 which was received on
July 6, 2009 has been recorded as a receivable due from a related party
(Fullbright Finance Limited, a beneficial holder of more than 5% of the
Company’s stock, participated in a Series D closing in the amount of $425,000 in
June 2009 and then made an additional investment of $375,000 which closed on
July 6, 2009; the Company understands that all securities purchased by
Fullbright in the June 2009 Private Placement were pledged to RimAsia, a
principal stockholder in the Company). The combined net proceeds from the two
private placements were $15,679,220. Since the April and June 2009 Private
Placements represent a combination of equities we are required to account for
the value of all equity securities associated with these private placements and
assign a portion of the net proceeds received to each equity
instrument. We apportioned and assigned the net proceeds of the two private
placements as follows: the value assigned to the Series D Stock was $7,685,768,
which includes the contingent value of the beneficial conversion to common stock
of $6,618,000, and the value assigned to the Series D Warrants was
$7,983,452.
The Series
D Warrants have a per share exercise price equal to $2.50 and are callable by
the Company if the common stock trades at a price equal to not less than $3.50
for a specified period of time. Subject to the affirmative vote of
the Company’s shareholders and the rules of the NYSE Amex, the Series D Warrants
will become exercisable for a period of five years.
Note 6 - Stockholders’
Equity
Common
Stock:
In
January 2009, the Company entered into an agreement with a physician who was
retained as a consultant. The term of this agreement is January 2009
through December 31, 2011. As part of the consideration for providing
services, the physician is to receive $24,000 annually, by the issuance of
shares of the Company’s Common Stock under the Company’s 2003 Equity
Participation Plan, as amended (the “2003 Equity Plan”) in equal monthly
installments of $2,000 on the last day of each month during the term of the
agreement at a per share purchase price equal to the closing price of the Common
Stock on the last day of each month, which payment shall be made in cash in the
event shares under the 2003 Equity Plan or any successor plan are
unavailable. During the three and six months ended June 30, 2009,
7,984 and 12,033 shares of Common Stock were issued, respectively, to the
physician pursuant to this agreement. The issuance of Common Stock resulted in
charges to operations for the three and six months ended June 30, 2009 of $6,000
and $11,998, respectively.
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relations services to the Company since 2005, pursuant
to which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The issuance of such securities was subject
to the approval of the NYSE Amex, which approval was obtained in May 2009. The stock issued to this
consultant had a value of $27,600 of which $11,040 and $27,600 were charged to
operations during the three and six months ended June 30, 2009, respectively,
based on the vesting of the Common Stock.
In
January 2009, the Company issued to its grant consultant, 20,000 shares of
restricted Common Stock, with a value of $13,800 as a bonus under the
consultant’s Consulting Agreement with the Company dated February 8, 2008, in
consideration for such consultant being instrumental in securing the Company’s
inclusion in the Department of Defense Fiscal Year 2009 Appropriations Bill in
the net amount of approximately $680,000. The issuance of such
securities was subject to the approval of the NYSE Amex, which approval was
obtained in January 2009. The Company has entered into a new
consulting agreement with this grant consultant for a one-year term commencing
as of January 1, 2009. In consideration for services, the consultant
will be issued shares of the Company’s restricted Common Stock equal to a value
of $60,000 based on the closing price of the Company’s Common Stock on the date
of execution of the agreement, which has been determined to be 67,416 shares, to
vest as to one-half of such shares on June 30, 2009 and the remaining one-half
of such shares on December 31, 2009. The issuance of such securities was
subject to the approval of the NYSE Amex, which approval was obtained in May
2009. For the three
and six months ended June 30, 2009 the Company has recognized $15,000 and
$30,000, respectively, as an operating expense relating to these
shares.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock, with a value of $8,280, pursuant to the terms of a
three month consulting agreement entered into in October 2008, scheduled to vest
pursuant to the agreement as to 4,000 shares at the end of each 30 day period
during the term. The issuance of such securities was subject to the
approval of the NYSE Amex, which approval was obtained in January 2009. The
issuance of Common Stock resulted in charges to operations for the three and six
months ended June 30, 2009 of $0 and $8,280, respectively.
In
January 2009, the Company issued to a member of its Scientific Advisory Board
20,000 shares of Common Stock under the 2003 Equity Plan, with a value of
$15,000, in consideration of this individual’s contribution to a special project
related to the design of a cardiac stem cell clinical trial for end stage
cardiomiopathy anticipated to be conducted in the People’s Republic of China.
The issuance of Common Stock resulted in charges to operations for the three and
six months ended June 30, 2009 of $0 and $15,000, respectively.
In
February 2009, the Company entered into a consulting agreement with a one year
term commencing March 1, 2009, with a physician to provide services to the
Company including providing medical expertise in the areas of apheresis and
laboratory medicine and to serve (as needed) as medical director for centers in
the Company’s stem cell collection center network as well as other related
activities, in partial consideration for which the physician is to receive a
one-time payment of 10,000 shares of Common Stock under the 2003 EPP, which
shares were issued as of February 2009. These shares had a value of
$8,000. The issuance of Common Stock resulted in charges to operations for the
three and six months ended June 30, 2009 of $0 and $8,000,
respectively.
In March
2009, the Company entered into an agreement with a consultant, pursuant to which
this consultant was retained to provide additional financial market related
services for a three month period. In partial consideration for
providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, with a
value of $17,250, to vest as to one-third of the shares at the end of each
monthly period during the term. The issuance of such securities was subject to
the approval of the NYSE Amex, which approval was obtained in May 2009. Based on these vesting
terms, the Company has recognized $11,500 and $17,250 as an operating expense in
the three and six months ended June 30, 2009, respectively. This
consultant was also issued a five year warrant to purchase 25,000 shares of
restricted Common Stock at a per share exercise price of $1.00, with a value of
$16,867. (See Warrants below).
In April
2009, the Company entered into an agreement with a consultant to provide
financial market related services to the Company. In partial
consideration for providing services under this agreement, the Company agreed to
issue to the consultant an aggregate of 20,000 shares of Common Stock, with a
value of $19,800. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in May 2009. The Company
has recognized $19,800 as an operating expense in the three and six months ended
June 30, 2009, respectively.
In April
2009, the Company entered into an agreement with a consultant to provide support
services in connection with our pending Merger to the Company. In
partial consideration for providing services under this agreement, the Company
agreed to issue to the consultant an aggregate of 10,000 shares of Common Stock,
with a value of $11,800. The issuance of such securities was subject to the
approval of the NYSE Amex, which approval was obtained in May 2009. The Company has
recognized $11,800 as an operating expense in the three and six months ended
June 30, 2009, respectively.
In May
2009, the Compensation Committee of the Board of Directors approved awards under
a Board of Directors Compensation Plan to members of the Board acting in their
capacity as Board members and to the Board Secretary, which included the
issuance of options under the Company’s newly adopted 2009 Equity
Compensation Plan (the “2009 Equity Plan”) and the authorization for the Chairs
of the Board and Board Committees to be issued for each Chair they
hold, either $25,000 or 25,000 shares of fully vested Common Stock under the
2009 Equity Plan. Accordingly, an aggregate of $50,000 was paid and
50,000 shares of Common Stock were awarded. The Common Stock issued
had a value of $97,500 which was charged to operations during the quarter ended
June 30, 2009.
In May
2009, the Company entered into a one month agreement with a consultant to
provide consulting services in the area of pharmaceutical research and the
development of strategic transactions. In partial consideration for
providing services under this agreement, the Company issued to the consultant
6,250 shares of Common Stock. The Common Stock issued had a value of
$11,876 which was charged to operations during the quarter ended June 30, 2009.
The consultant joined the Company as its Vice President, Drug Development and
Regulatory Affairs in July 2009.
Warrants:
The
Company has issued common stock purchase warrants from time to time to investors
in private placements, certain vendors, underwriters, and directors and officers
of the Company. A total of 18,262,204 shares of common stock are reserved for
issuance upon exercise of outstanding warrants as of June 30, 2009 at prices
ranging from $.50 to $8.00 and expiring through June 2014.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of Common Stock at a purchase price of $1.40 per share,
with a value of $3,338. This warrant was issued in consideration of services
rendered after the expiration of an October 2007 consulting agreement with the
Company pursuant to which this consultant was engaged to create marketing
materials for our sales and marketing staff. The issuance of this warrant was
approved by the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant to provide
financial market related services for a three month period beginning March
2009. As partial consideration for providing services under this
agreement, the Company agreed to issue to the consultant a five year warrant to
purchase 25,000 shares of restricted Common Stock at a per share exercise price
of $1.00, with a value of $16,867, vesting in its entirety at the end of the
term. The issuance of such securities was subject to the
approval of the NYSE Amex, which approval was obtained in May 2009. The Company recognized
$11,245 and $16,867 as an operating expense for the three and six months ended
June 30, 2009, respectively.
In the
Company’s August 2007 public offering, units were issued comprised of shares of
the Company’s Common Stock, and Class A warrants to purchase an aggregate of
635,000 shares of Common Stock. The Company also issued to its
underwriter group warrants (the “Underwriter Warrants”) to purchase an aggregate
of 95,250 shares of Common Stock. The Class A Warrants were issued
pursuant to the terms of a Restated Warrant Agreement made as of August 14, 2007
between the Company and the Class A Warrant agent. The Underwriter
Warrants were issued individually to each member of the underwriting
group. The Underwriter Warrants had a higher exercise price ($6.50)
than that of the Class A Warrants, and unlike the Class A Warrants, could not be
exercised for a period of one year from the date of issuance and contained
provisions for cashless exercise. In September, 2008 the Company made the
determination that certain of the Underwriter Warrants totaling 86,865 shares of
Common Stock, should be accounted for as a derivative liability and reported on
our balance sheet as such. Upon the closing of our August 2007 public offering
the fair value and thus the derivative liability value of these certain
Underwriter Warrants was $195,551. At December 31, 2008 the derivative liability
value associated with these certain Underwriter Warrants was $0 and at June 30,
2009 the derivative liability value of these Underwriter Warrants was $42,892
and has been reflected as an accrued liability on our balance
sheet.
In the
April and June 2009 Private Placements (described in Note 5 - Redeemable
Preferred Stock, above), as part of the Series D Units issued at $12.50 per
unit, the Company issued 8,800,000 Series D Warrants, and 4,002,800 Series D
Warrants, respectively, to investors, each to purchase one share of Common
Stock. The Company also issued 129,712 Series D Warrants to selling
agents that facilitated the June 2009 Private
Placement. The Series D Warrants have a per share exercise
price equal to $2.50 and are callable by the Company if the Common Stock trades
at a price equal to not less than $3.50 for a specified period of
time. Subject to the affirmative vote of the Company’s shareholders
and the rules of the NYSE Amex, the Series D Warrants will become exercisable
for a period of five years. The combined net proceeds from the two
private placements were $15,679,220. Since the April and June 2009 Private
Placements represent a combination of equities we are required to account for
the value of all equity securities associated with these private placements and
assign a portion of the net proceeds received to each equity instrument. We
apportioned and assigned the net proceeds of the two private placements as
follows: the value assigned to the Series D Stock was $7,685,768, which includes
the contingent value of the beneficial conversion to common stock of $6,618,000,
and the value assigned to the Series D Warrants was $7,983,452.
On May 1,
2009, the Company entered into a three year consulting agreement effective March
3, 2009 (the “Effective Date”) whereby the consultant would provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia. Pursuant to this agreement, as
partial compensation for such services, the Company agreed to issue to this
consultant a warrant to purchase up to an aggregate of 24,000 shares of Common
Stock at an exercise price of $0.50 (the closing price of the Common Stock on
the Effective Date) which shall vest and become exercisable as to one-third of
such shares on each of the first, second and third anniversaries of the
Effective Date. The value of such warrants is approximately
$27,300. The issuance of such securities is subject to the approval
of the NYSE Amex.
Warrant
activity is as follows:
|
|
Number of
Shares
|
|
|
Range of
Exercise Price
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
|
Aggregate
Intrinsic
Value
|
|
Balance
December 31, 2008
|
|
|
5,322,333
|
|
|
$
|
0.50
- $8.00
|
|
|
$
|
3.66
|
|
|
|
|
|
|
|
Granted
|
|
|
12,986,512
|
|
|
|
|
|
|
|
2.49
|
|
|
|
|
|
|
|
Exercised
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(46,641
|
)
|
|
|
|
|
|
|
9.07
|
|
|
|
|
|
|
|
Cancelled
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
June 30, 2009
|
|
|
18,262,204
|
|
|
$
|
0.50
- $8.00
|
|
|
$
|
2.82
|
|
|
|
4.53
|
|
|
$
|
1,170,956
|
|
|
|
|
|
|
|
Number
|
|
|
Weighted Average
Remaining
|
|
|
Number
|
|
Exercise Price
|
|
|
Outstanding
June 30, 2009
|
|
|
Contractual Life
(years)
|
|
|
Exercisable
June 30, 2009
|
|
$ |
0.50 to |
|
|
$ |
3.02 |
|
|
|
16,252,221 |
|
|
|
4.70
|
|
|
|
3,141,546 |
|
$ |
3.02 to |
|
|
$ |
5.27 |
|
|
|
184,250 |
|
|
|
2.66
|
|
|
|
184,250 |
|
$ |
5.27 to |
|
|
$ |
7.51 |
|
|
|
802,761 |
|
|
|
3.19
|
|
|
|
802,761 |
|
$ |
7.51 to |
|
|
$ |
8.00 |
|
|
|
1,022,972 |
|
|
|
3.14
|
|
|
|
1,022,972 |
|
|
|
|
|
|
|
|
|
|
18,262,204 |
|
|
|
|
|
|
|
5,151,529 |
|
Options:
The
Company’s 2003 Equity Participation Plan (the “2003 Equity Plan”) and newly
approved 2009 Equity Compensation Plan (the “2009 Equity Plan”) permit the grant
of share options and shares to its employees, directors, consultants and
advisors for up to an aggregate of 6,300,000 shares of Common Stock as
stock-based compensation. All stock options under the 2003 Equity
Plan and the 2009 Equity Plan are generally granted at the fair market value of
the Common Stock at the grant date. Stock options vest either on the date of
grant, ratably over a period determined at time of grant, or upon the
accomplishment of specified business milestones, and generally expire 10 years
from the grant date.
On May 8,
2009, the stockholders of the Company at its annual meeting of stockholders
adopted the 2009 Equity Plan, which previously had been approved by the Board of
Directors subject to stockholder approval on April 9, 2009. The 2009
Equity Plan makes up to 3,800,000 shares of Common Stock of the Company
available for issuance to employees, consultants, advisors and directors of the
Company and its subsidiaries pursuant to incentive or non-statutory stock
options, restricted and unrestricted stock awards and stock appreciation
rights.
The 2003
Equity Plan and the 2009 Equity Plan are sometimes collectively referred to as
the Company’s “U.S. Equity Plan.”
Effective
January 1, 2006, the Company’s U.S. Equity Plan has been accounted for in
accordance with the recognition and measurement provisions of Statement of
Financial Accounting Standards ("FAS") No. 123 (revised 2004), Share-Based
Payment ("FAS 123(R)"), which replaces FAS No. 123, Accounting for Stock-Based
Compensation, and supersedes Accounting Principles Board Opinion ("APB") No. 25,
Accounting for Stock Issued to Employees, and related interpretations. FAS 123
(R) requires compensation costs related to share-based payment transactions,
including employee stock options, to be recognized in the financial statements.
In addition, the Company adheres to the guidance set forth within Securities and
Exchange Commission ("SEC") Staff Accounting Bulletin ("SAB") No. 107, which
provides the Staff's views regarding the interaction between SFAS No. 123(R) and
certain SEC rules and regulations and provides interpretations with respect to
the valuation of share-based payments for public companies.
The
Company's results included share-based compensation expense of $1,338,617 and
$556,802 for the three months ended June 30, 2009 and 2008, respectively and
$1,398,387 and $1,202,223 for the six months ended June 30, 2009 and 2008,
respectively. Such amounts have been included in the consolidated statements of
operations within general and administrative expenses.
Stock
option compensation expense is the estimated fair value of options granted
amortized on a straight-line basis over the requisite service period for the
entire portion of the award and those options that vested upon the
accomplishment of business milestones. Options vesting on the accomplishment of
business milestones will not be recognized for compensation purposes until such
milestones are accomplished. At June 30, 2009 there were options to purchase
275,000 shares outstanding that will vest on the accomplishment of certain
business milestones.
The
weighted average estimated fair value of stock options granted in the three
months ended June 30, 2009 and 2008 were $1.96 and $1.12, respectively and
for the six months ended June 30, 2009 and 2008 the weighted average estimated
fair value of stock options granted were $1.96 and $1.52, respectively.
The fair value of options at the date of grant was estimated using the
Black-Scholes option pricing model. During the six months ended June 30, 2009
and the years ended 2008, 2007 and 2006, the Company took into consideration the
guidance under SFAS 123(R) and SAB No. 107 when reviewing and updating
assumptions. The expected volatility is based upon historical volatility of our
stock and other contributing factors. The expected term is based upon
observation of actual time elapsed between date of grant and exercise of options
for all employees. Previously such assumptions were determined based
on historical data.
The range
of assumptions made in calculating the fair values of options are as
follows:
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Expected
term (in years)
|
|
10
|
|
|
10
|
|
|
10
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
volatility
|
|
195%
to 217%
|
|
|
100%
to 140%
|
|
|
195%
to 217%
|
|
|
100%
to 140%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
dividend yield
|
|
0%
|
|
|
0%
|
|
|
0%
|
|
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
3.35%
to 3.81%
|
|
|
3.83%
to 4.19%
|
|
|
3.35%
to 3.81%
|
|
|
3.64%
to 4.19%
|
|
Stock
option activity under the US Equity Plan is as follows:
|
|
Number of
Shares (1)
|
|
|
Range of
Exercise Price
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
|
Aggregate
Intrinsic
Value
|
|
Balance
December 31, 2008
|
|
|
1,725,300 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
3.96 |
|
|
|
|
|
|
|
Granted
|
|
|
850,000 |
|
|
|
|
|
|
|
1.98 |
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(2,000
|
) |
|
|
|
|
|
|
7.00 |
|
|
|
|
|
|
|
Cancelled
|
|
|
(7,500
|
) |
|
|
|
|
|
|
1.00 |
|
|
|
|
|
|
|
Balance
June 30, 2009
|
|
|
2,565,800 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
3.31 |
|
|
|
8.62 |
|
|
$ |
279,845 |
|
Vested
and Exercisable at June 30, 2009
|
|
|
2,094,300 |
|
|
|
|
|
|
$ |
3.38 |
|
|
|
8.52 |
|
|
$ |
224,395 |
|
(1) —
All options are exercisable for a period of ten years.
|
|
|
|
|
|
Number
|
|
|
Weighted
Average
Remaining
|
|
|
Number
|
|
Exercise Price
|
|
|
Outstanding
June 30, 2009
|
|
|
Contractual Life
(years)
|
|
|
Exercisable
June 30, 2009
|
|
$ |
0.71 to |
|
|
$ |
4.17 |
|
|
|
1,674,500 |
|
|
|
9.25
|
|
|
|
1,368,000 |
|
$ |
4.17 to |
|
|
$ |
7.63 |
|
|
|
800,200 |
|
|
|
7.61
|
|
|
|
639,200 |
|
$ |
7.63 to |
|
|
$ |
11.08 |
|
|
|
50,000 |
|
|
|
6.46
|
|
|
|
46,000 |
|
$ |
11.08 to |
|
|
$ |
14.54 |
|
|
|
3,000 |
|
|
|
4.67
|
|
|
|
3,000 |
|
$ |
14.54 to |
|
|
$ |
25.00 |
|
|
|
38,100 |
|
|
|
6.02
|
|
|
|
38,100 |
|
|
|
|
|
|
|
|
|
|
2,565,800 |
|
|
|
|
|
|
|
2,094,300 |
|
Options
are usually granted at an exercise price at least equal to the fair value of the
Common Stock at the grant date and may be granted to employees, directors,
consultants and advisors of the Company.
As of
June 30, 2009, there was approximately $1,392,179 of total unrecognized
compensation costs related to unvested stock option awards of which $424,594 of
unrecognized compensation expense is related to stock options that vest over a
weighted average life of 1.27 years. The balance
of $967,584 of unrecognized compensation costs is related to stock options that
vest based on the accomplishment of business milestones.
|
|
Options
|
|
|
Weighted Average
Grant Date Fair
Value
|
|
Non-Vested
at December 31, 2008
|
|
|
435,250 |
|
|
$ |
2.93 |
|
Issued
|
|
|
850,000 |
|
|
|
1.96 |
|
Expired
|
|
|
(2,000 |
) |
|
|
7.00 |
|
Canceled
|
|
|
(7,500 |
) |
|
|
1.00 |
|
Vested
|
|
|
(804,250 |
|
|
|
1.90 |
|
Exercised
|
|
|
- |
|
|
|
|
|
Non-Vested
at June 30, 2009
|
|
|
471,500 |
|
|
$ |
2.96 |
|
The total
value of shares vested during the six months ended June 30, 2009 was
$1,398,387.
The
number of remaining shares authorized to be issued for the U.S. Equity Plan is
as follows
Shares
authorized for Issuance under the 2003 Equity Plan
|
|
|
2,500,000
|
|
Shares
authorized for Issuance under the 2009 Equity Plan
|
|
|
3,800,000
|
|
Options
Outstanding
|
|
|
(2,565,800)
|
|
Common
Stock Issued
|
|
|
(834,185)
|
|
Options
Exercised
|
|
|
(2,500)
|
|
Remaining
shares authorized to be issued as of June 30, 2009
|
|
|
2,897,515
|
|
Note 7 - Segment
Information
Historically,
the Company’s operations have been conducted in only one geographical segment
and since March 31, 2007 the Company has realized revenue only from the banking
of adult autologous stem cells. In June, 2009 the Company established NeoStem
(China), Inc. (“NeoStem China” or the “WFOE”) as a wholly foreign owned
subsidiary of NeoStem. The WFOE is domiciled in Qingdao and under its scope of
business approved by the Chinese regulatory authorities, the WFOE may engage in
the research & development, transfer and technological consultation service
of bio-technology, regenerative medical technology and anti-aging technology
(excluding the development or application of human stem cell, gene diagnosis and
treatment technologies); consultation of economic information; import, export
and wholesaling of machinery and equipments (the import and export do not
involve the goods specifically stipulated in/by state-operated trade, import
& export quota license, export quota bidding, export permit, etc.). In
furtherance of complying with PRC’s foreign investment prohibition on stem cell
research and development, clinical trials and related activities, we conduct our
current business in the PRC via two domestic variable interest entities. To date
operations in China have been limited. Our segment data is as
follows:
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Revenues
earned from external customers:
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$ |
31,600 |
|
|
$ |
23,500 |
|
|
$ |
76,700 |
|
|
$ |
24,200 |
|
China
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss)
from operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$ |
(3,856,400 |
) |
|
$ |
(2,361,800 |
) |
|
$ |
(5,539,000 |
) |
|
$ |
(4,884,100 |
) |
China
|
|
$ |
(1,086,700 |
) |
|
|
- |
|
|
$ |
(1,271,400 |
) |
|
|
- |
|
Note 8 - Related Party
Transactions
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed Merger and Share Exchange
transactions, other initiatives in China as well as other ongoing obligations of
the Company, on February 25, 2009 and March 6, 2009, respectively, the Company
issued promissory notes to RimAsia Capital Partners , L. P. (“RimAsia”), a
principal stockholder of the Company, in the principal amounts of $400,000 and
$750,000, respectively. The notes bore interest at the rate of 10%
per annum and were due and payable on October 31, 2009, except that all
principal and accrued interest on the Notes was immediately due and payable in
the event the Company raised over $10 million in equity financing prior to
October 31, 2009. The notes contained standard events of default and
in the event of a default that was not subsequently cured or waived, the
interest rate would increase to a rate of 15% per annum and, at the option of
RimAsia and upon notice, the entire unpaid principal balance together with all
accrued interest thereon would be immediately due and payable. The
notes or any portion thereof could be prepaid at any time and from time to time
at the discretion of the Company without premium or penalty. On April 9, 2009
these notes and the related accrued interest were repaid from the proceeds of
the April 2009 Private Placement. In addition, April 9, 2009 NeoStem paid
RimAsia $472,559 for
reimbursement of funds advanced by RimAsia in connection with NeoStem’s
expansion activities in China.
In order
to accelerate the establishment of Qingdao Niao for research and development
purposes in the PRC, in April 2009 Suzhou Erye Pharmaceuticals Company Ltd.
(“Erye”) advanced in Renminbi the U.S. dollar equivalent of $176,000 to the
shareholder of Qingdao Niao on our behalf. In May 2009 we repaid the
amount of $176,000 to Erye. Erye is owned 51% by CBH (with which we have
entered into the Merger Agreement) and 49% by Erye Economy and Trading Co. Ltd
(of which Fullbright Finance Limited, a beneficial holder of more than five
percent of the Company’s stock, is a wholly-owned subsidiary).
On April
30, 2009 the Company entered into a License and Referral Agreement with
Promethean Corporation (“Promethean”) through its subsidiary Ceres Living, Inc.
(“Ceres”) to use certain Company marks and publications in connection with
certain sales and marketing activities relating to its nutritional supplement
known as AIO Premium Cellular (the “Product”); and in connection with the
license, Ceres will pay to the Company or the Stem for Life Foundation specified
fees for each unit of the Product sold; and Ceres shall
engage in a referral service with respect to the Company’s adult stem cell
collection and storage activities. Ceres will receive a specified fee from the
Company for each client referred who completes and pays for a stem cell
collection. The term of the agreement is three years with each party having the
right to renew annually, thereafter. The CEO of Promethean is in an exclusive
relationship with the CEO of the Company.
As part
of the stem cell initiatives undertaken by NeoStem, on June 15, 2009, NeoStem
signed a ten-year, exclusive, royalty bearing agreement with Enhance BioMedical
Holdings Limited (“Enhance”) to provide Enhance with the training, technical,
and other assistance required for Enhance to offer stem cell based therapies in
Taiwan, Shanghai, and five other provinces in eastern China including Jiangsu,
Zhejiang, Fujian, Anhui and Jiangxi. This agreement also gives NeoStem the
option to acquire up to a 20% fully diluted equity interest in Enhance for a
period of five years. NeoStem will receive certain milestone payments as well as
be entitled to a stated royalty on the revenues derived from Enhance’s offering
these stem cell based therapies. Enhance was an investor in the April
2009 Private Placement, pursuant to which it purchased $5 million of Series D
Units, and thus acquired 400,000 shares of Series D Stock (convertible into
4,000,000 shares of Common Stock upon stockholder approval) and 4,000,000 Series
D Warrants, each to purchase one share of Common Stock at an exercise price of
$2.50 per share (to become exercisable upon stockholder approval).
Note 9 –
Commitments
The
Company has entered into an agreement for the lease of executive office space
from SLG Graybar Sublease LLC (the “Landlord”) at Suite 450, 420 Lexington
Avenue, New York, with a lease term effective April 1, 2009 through June 30,
2013 (the “Lease”). Rental, storage and utility payments are
currently in the aggregate approximate monthly amount of $20,600. To
help defray the cost of the Lease, the Company has licensed to third parties the
right to occupy certain of the offices in Suite 450 and use certain business
services. Such license payments currently total approximately $11,360
per month and the license agreements are for periods of one year or
less. The CEO of one such licensee, Promethean Corporation, is in an
exclusive relationship with the Company’s CEO. The Lease was entered into
pursuant to an assignment and assumption of the original lease from the original
lessor thereof, DCI Master LDC (the lead investor in a private placement by the
Company in June 2006) and affiliates of DCI Master LDC and Duncan Capital Group
LLC (a former financial advisor to and an investor in the Company), for which
original lease a principal of such entities acted as guarantor (the
“Guarantor”), a consent to such assignment from the Landlord and a lease
modification agreement between the Company and the Landlord, such documents
being dated April 13, 2009 with effective delivery April 17,
2009. The Company was credited with an amount remaining as a security
deposit with the Landlord from such original lessor (the “Security Deposit
Credit”), was required to deposit an additional amount with the Landlord to
replenish the original amount of security for the Lease and pay an amount equal
to the Security Deposit Credit to the Guarantor of the original
lease. The total payments made by the Company for such security
deposit and payment of the Security Deposit Credit to the Guarantor were in the
approximate aggregate amount of $157,100. Richard Berman, a director of the
Company, utilizes an office in Suite 450 in his capacity as a member of the
Company’s Audit Committee and Chairman of the Company’s Compensation and
Nominating Committees, and for other business purposes.
In May
2009, Qingdao Niao, the Chinese domestic company controlled by the WOFE, NeoStem
China, through various business arrangements, entered into leases
with Beijing Zhong-guan-cun Life Science Park Development Corp., Ltd. pursuant
to which Qingdao Niao is leasing laboratory, office and storage space in Beijing
for the aggregate monthly amount of approximately $23,000. Lease
payments are due quarterly in advance, and upon entering into the lease a three
month security deposit was required in addition to the first quarterly
payment. The term of the leases is for approximately three
years.
Note 10 - Subsequent
Events
The
following are the subsequent events that management believes materially effect
the financial position or results of operations or are otherwise informative to
the reader of these financial statements from July 1, 2009 to August 12,
2009.
As of
July 1, 2009, the Company entered into an Amendment No. 1 to Agreement and Plan
of Merger with China Biopharmaceuticals Holdings, Inc. (“CBH”), China
Biopharmaceuticals Corp., CBH’s wholly-owned subsidiary (“CBC”) and CBH
Acquisition LLC, NeoStem’s wholly-owned subsidiary. Pursuant to the
terms of the Amendment:
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·
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The number of shares of NeoStem
Common Stock to be issued to the CBH Common Stockholders was reduced to an
aggregate of 7,150,000 shares (such that the Exchange Ratio in the Merger
will be 0.19255), with no additional shares being
escrowed;
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·
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The number of shares to be issued
to RimAsia Capital Partners, L.P. ("RimAsia") will be increased to
6,458,009 shares of Common Stock and 8,177,512 shares of NeoStem Series C
Convertible Preferred Stock, each with a liquidation preference of $1.125
and convertible to shares of NeoStem Common Stock at an initial conversion
price of $.90 (with the Class B warrants to be issued to RimAsia
eliminated), in exchange for certain advances made or to be
made by RimAsia and described
below;
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·
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125,000 shares of NeoStem Common
Stock will be issued to Erye Economy and Trading Co. Ltd. (“EET”) (the 49%
holder of Suzhou Erye Pharmaceuticals Company Ltd. (“Erye”), 51% of
which is owned by CBH and which 51% will be acquired by NeoStem in the
Merger) or its designee for assistance in effectuating the
Merger;
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·
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The number of shares to be issued
to Steven E. Globus and Chris Mao, respectively a director and CEO of CBH,
in exchange for satisfaction of loans made by them to CBH, shall be
reduced to an aggregate of approximately 17,158
shares;
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·
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Conditions to closing were
amended to (a) add a condition that in order to satisfy its obligations
under a memorandum of understanding with EET, CBH shall have caused Erye
to transfer the land and building for its principal manufacturing facility
to EET or its affiliate for a sum to be agreed upon, and for EET or its
affiliate to lease that facility back to Erye at a nominal fee for a term
through construction of Erye's new manufacturing facility and until such
date as Erye’s new facility is completed and fully operational (which
transaction will remove a significant asset from the CBH balance sheet)
and (b) provide that instead of a spinoff of the CBC shares as a
liquidating distribution to the shareholders of CBH, such shares may be
privately sold or transferred to a liquidating
trust;
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·
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Eric Wei (a principal of RimAsia)
will be added to the current NeoStem Board of Directors after the Merger
is effected, and thereafter, Shi Mingsheng (a principal of EET and
Fullbright and a current director of CBH) will also be added after receipt
of PRC approvals;
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Privately issued NeoStem warrants
outstanding immediately prior to the closing of the Merger shall be
amended to reduce their exercise price if the current exercise price is
$4.00 and above;
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·
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The Compensation Committee of
NeoStem’s Board of Directors may in lieu of lowering the exercise price of
outstanding options to $.80 as provided in the original merger agreement,
lower the exercise price to a price which is greater than $.80 (but not
less than fair market value) and provide alternative cash or equity
consideration to eligible NeoStem employees, directors, advisors and
consultants;
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·
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The
outside date for completion of the Merger is extended to October 31,
2009.
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Additionally,
as of July 1, 2009, NeoStem, CBH, CBC and RimAsia, which is a significant
investor in the Company and CBH, entered into a Funding Agreement pursuant to
which it was agreed that RimAsia shall supply additional funding to both NeoStem
and CBH in an amount up to $1.6 million (including approximately $1 million
advanced to date), which amount shall be deemed settled upon its receipt of the
increased amount of NeoStem securities described above to be received by RimAsia
as part of the Merger consideration. If less than $1.6 million has
been advanced at that time, the difference shall be paid to NeoStem at the
closing of the merger. In the event the Merger has not received
shareholder approval by October 31, 2009, NeoStem is required to repay RimAsia
all payments incurred or made by RimAsia on behalf of
NeoStem.
On July
6, 2009, the Company entered into an employment agreement with Alan Harris,
M.D., Ph.D. (the “Employment Agreement”), pursuant to which Dr. Harris will
serve as the Company’s Vice President of Drug Development and Regulatory Affairs
for a period of three years from July 6, 2009 (the “Commencement Date”), unless
such term is earlier terminated by Dr. Harris or the Company in accordance with
the provisions of the Employment Agreement. In this capacity, Dr.
Harris will be responsible for overseeing the research, development and
regulatory activities of the Company; overseeing the regulatory activities of
the Company; assisting in the preparation and submission of grant applications
for funding; advancing the Company’s intellectual property portfolio, as well as
other activities. In consideration for his services to the Company,
Dr. Harris shall receive a fixed annual salary of $240,000 and shall be entitled
to participate in the Company’s compensation and employee benefit plans and
programs.
On the
Commencement Date, Dr. Harris was granted an option to purchase 150,000 shares
of the Company’s Common Stock under the Company’s 2009 Equity Plan at an
exercise price equal to the closing price of the Common Stock on the date of
grant. The option vests as to 50,000 shares immediately and as to the
remaining 100,000 shares on the one year anniversary of the Commencement
Date. Upon (i) shareholder approval of the proposal to expand the
option pool available under the 2009 Equity Plan and (ii) the consummation of
the Merger with CBH, Dr. Harris shall be granted an option to purchase 200,000
shares of Common Stock at an exercise price equal to the closing price of the
Common Stock on the date of grant. This option shall vest as to
100,000 shares on the second anniversary of the Commencement Date and as to the
remaining 100,000 shares on the third anniversary of the Commencement
Date. The options granted to Dr. Harris shall be subject to written
option grant agreements. In the event Dr. Harris is terminated other
than for Cause (as defined in the Employment Agreement) within thirty days of a
vesting date, the vesting of the applicable shares of Common Stock shall
accelerate.
Additionally,
upon the achievement of certain Milestones as set forth in the Employment
Agreement, Dr. Harris shall receive a cash bonus of $15,000, payable within
thirty days of the achievement of a Milestone. Dr. Harris shall also
receive (i) reimbursement of $1,500 per month for health benefits; (ii) a $1,000
per month car allowance; and (iii) reimbursement for all reasonable travel and
other reasonable expenses (in accordance with the Company’s policy) incurred by
him in connection with the performance of his duties and obligations under the
Employment Agreement.
The
Company may terminate Dr. Harris’ employment prior to the expiration of the
three-year term immediately upon written notice to Dr. Harris. Dr.
Harris may terminate his employment with the Company upon sixty days prior
written notice. If the Company terminates Dr. Harris’ employment
other than for Cause (as defined in the Employment Agreement), the Company shall
pay Dr. Harris severance equal to two months of base salary, payable on Dr.
Harris’ regular payroll dates. Except as describe above, Dr. Harris’
options shall not vest beyond his termination date. No other payments
shall be made, or benefits provided, to Dr. Harris by the Company except as
otherwise required by law.
Dr.
Harris previously executed a Confidentiality, Non-Compete and Inventions
Assignment Agreement pursuant to which Dr. Harris agreed to be bound by certain
non-compete provisions and certain non-solicitation provisions during the term
of his employment with the Company.
On July
8, 2009, pursuant to a letter agreement (the “Letter Agreement”) entered into
with Catherine M. Vaczy, Esq., the Vice President and General Counsel the
Company, the Company reinstated and extended Ms. Vaczy’s employment agreement
dated January 26, 2007, which employment agreement was amended on January 9,
2008 and August 29, 2008 (the “Original Agreement”). The Letter
Agreement was effective as of July 8, 2009 (the “Effective Date”) and continues
for a one year term (the “Term”). In consideration for Ms. Vaczy’s
services during the Term, Ms. Vaczy shall receive a base salary of
$182,500.
Upon the
Effective Date, Ms. Vaczy shall receive (i) a stock award under the Company’s
2009 Equity Plan for 25,000 shares of Common Stock and (ii) an option grant for
200,000 shares of Common Stock under the Company’s 2009 Equity Plan with an
exercise price equal to the closing price of the Common Stock on the date of
grant, which option shall vest with respect to 100,000 shares on the Effective
Date and with respect to the remaining 100,000 shares upon shareholder approval
of the Company’s proposed Merger with CBH. Options granted to Ms.
Vaczy shall remain exercisable for a period of two years following her
termination of employment with the Company.
Additionally,
upon shareholder approval of (i) the proposal to expand the option pool
available under the 2009 Equity Plan and (ii) the merger with CBH, Ms. Vaczy
shall be granted an option for 100,000 shares of Common Stock, which option
shall vest in full on the first anniversary of the Effective
Date. Ms. Vaczy shall also be entitled to a $5,000 cash bonus upon
the achievement of each of two stated business milestones. Pursuant
to the Letter Agreement, any severance payments to which Ms. Vaczy may become
entitled under her Original Agreement shall be based upon her then-current
salary for a three-month period.
On July
8, 2009, the Company granted under its 2009 Equity Plan to certain employees,
directors, consultants and advisors, (i) options to purchase an aggregate of
1,330,000 shares of Common Stock at a per share exercise price equal to $1.71
which was the closing price of the Common Stock on the date of grant and (ii) an
aggregate of 525,000 shares of Common Stock. A total of 900,000 options
and 525,000 shares were granted to officers and a director. In lieu of
cash bonuses to certain officers, the Company has agreed to pay taxes associated
with the issuances of the shares of Common Stock granted to the officers in a
total amount estimated to be $583,400.
On July
13, 2009, the Company terminated in accordance with the terms thereof the Share
Exchange Agreement dated November 2, 2008 (the "Share Exchange Agreement") by
and between NeoStem, China StemCell Medical Holding Limited, a Hong Kong company
(the "HK Entity"), Shandong New Medicine Research Institute of Integrated
Traditional and Western Medicine Limited Liability Company, a China limited
liability company (the "Institute Co. ") (its
preexistence is Shandong New Medicine Research Institute of Integrated
Traditional and Western Medicine, “Institute”), Beijing HuaMeiTai Bio-technology
Limited Liability Company (“WFOE”) and Zhao Shuwei (“HK
Shareholder”). The Share Exchange Agreement provided for a
transaction whereby NeoStem would acquire rights in the Institute Co. in
connection with NeoStem's planned expansion into the PRC. As a result
of the termination, the Company will be relieved of issuing the 5,000,000 shares
of its Common Stock that would have been issued under the Share Exchange
Agreement. Beginning in 2009, NeoStem embarked on other
activities to expand its operations into the PRC through a stem cell division
that will be in place of closing on the transactions contemplated by the Share
Exchange Agreement. As a result on July 13, 2009, NeoStem terminated
the Share Exchange Agreement and is in discussions regarding the possibility of
acquiring an option to purchase the Institute Co. during the next three
years.
On July
15, 2009, the Company filed with the SEC a Proxy Statement/Registration
Statement on Form S-4 in connection with the Merger.
In July
2009, in connection with NeoStem’s determination to terminate its proposed Share
Exchange transaction in favor of independently building out its stem cell
business in China, NeoStem expanded its relationship with Shandong Life Science
and Technology Research Institute (“SLSI”), of which Dr. Cai Jianqian of the
Shandong Provincial Association of Chinese Medicine is President, to provide for
commitments from SLSI in addition to those agreed to effective April 23, 2009
(described below). In return, NeoStem has agreed to grant to SLSI an
additional 100,000 shares under its 2009 Non-U.S. Based Equity Plan (the “2009
Non-U.S. Plan”), subject to approval of the 2009 Non-U.S. Plan at the Company’s
Special Meeting of Shareholders to be held in connection with the proposed
Merger with CBH. Previously, effective April 23, 2009, the Company
had entered into a Consulting Agreement with SLSI. Through SLSI, Dr.
Cai Jianqian will provide consulting services to NeoStem in the area of business
development, strategic planning and government affairs in the healthcare
industry in the PRC, including the introduction of NeoStem to hospitals and
medical practices within the PRC to advance NeoStem’s strategic relationships.
In return, NeoStem will pay SLSI an annual fee of $100,000 and issue SLSI an
aggregate of 250,000 options under the NeoStem, Inc. 2009 Non-U.S. Plan, subject
to the approval of the 2009 Non-U.S. Plan at the Special Meeting, to become
exercisable over approximately a two year period. Dr. Cai Jianqian
became acquainted with the Company through her son Chris Peng Mao, CEO of
CBH.
On July
29, 2009, the Company amended the terms of its employment agreement with its
Chief Executive Officer, Dr. Robin Smith to extend the term of Dr. Smith’s
employment to December 31, 2011 and subject to consummation of the
proposed Merger with CBH, awarded to Dr Smith a $275,000 cash bonus for
2009 and comparable minimum annual bonuses for 2010 and 2011.
Effective
as of July 27, 2009, NeoStem (China), Inc., a wholly foreign owned subsidiary of
the Company in China (the “WFOE”), entered into an employment agreement with
Peter Sun (the “Employment Agreement”), pursuant to which Mr. Sun will serve as
the WFOE’s General Manager for a period of three years from July 27, 2009 (the
“Commencement Date”), unless such term is earlier terminated by Mr. Sun or the
WFOE in accordance with the provisions of the Employment
Agreement. In this capacity, Mr. Sun will be responsible for
overseeing the entire business, from the validation of WFOE’s business plan, to
the execution of the WFOE’s strategy. Pursuant to the Employment
Agreement, in consideration for his services to the WFOE, Mr. Sun shall receive
a fixed annual salary and a monthly allowance to cover various expenses incurred
by him in connection with the performance of his duties and obligations under
the Employment Agreement. He shall also be entitled to receive
employee benefits as required by Labor Contract Law of the People’s Republic of
China (the “Chinese Labor Contract Law”). Upon the approval by the
Company’s shareholders of its proposed Merger with CBH and the Company’s 2009
Non-US Based Equity Compensation Plan (the “Non-U.S. Plan”), subject to the
rules of the NYSE Amex and further subject to all the terms and conditions of
the Non-U.S. Plan, Mr. Sun shall be granted a stated warrant under the Non-U.S.
Plan at an exercise price equal to the closing price of the Common Stock on the
date of grant, subject to approval of the Company’s Compensation Committee of
Board which vests based on the achievement of certain milestones as set forth in
the Employment Agreement.
The
Company or Mr. Sun may terminate this Employment Agreement according to certain
provisions of Chinese Labor Contract Law. If Mr. Sun’s employment is
terminated due to causes set forth under Chinese Labor Contract Law, the Company
shall pay Mr. Sun the severance based on the number of years he has worked for
the Company at the rate of one month’s wages for each full year
worked. Mr. Sun has also executed a Confidentiality and Non-Compete
Agreement pursuant to which Mr. Sun agreed to be bound by certain non-compete
provisions and certain non-solicitation provisions.
In July
2009, the WOFE entered into a cooperation agreement with NeoStem’s PRC
consultant, Shandong Life and Science Institute, a not-for-profit organization
under PRC law, to organize and convene various clinical trials. This agreement
requires funding by the WOFE in the amount of RMB 5,000,000 (approximately
$730,000).
In August
2009 the Company entered into an additional services agreement with PCT pursuant
to which PCT will provide advice, drawings, documents, equipment lists and other
deliverables in connection with developing the Beijing laboratory. The
Company is required to pay $60,000 to PCT for these services, $30,000 of which
was paid upon execution of the agreement. The Company agreed to pay an
additional $15,000 to PCT in the event PCT completes the services on an
expedited basis.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
FORWARD
LOOKING STATEMENTS
General
This
Quarterly Report on Form 10-Q and the documents incorporated herein contain
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. When used in this
Quarterly Report, statements that are not statements of current or historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, the words "plan," "intend," "may," "will," "expect," "believe,"
"could," "anticipate," "estimate," or "continue" or similar expressions or other
variations or comparable terminology are intended to identify such
forward-looking statements. Additionally, statements concerning our ability to
successfully develop the adult stem cell business at home and abroad, the future
of regenerative medicine and the role of adult stem cells in that future, the
future use of adult stem cells as a treatment option and the role of VSELs in
that future, and the potential revenue growth of such business are
forward-looking statements. Our future operating results are
dependent upon many factors, and the Company's further development is highly
dependent on future medical and research developments and market acceptance,
which is outside its control. Forward-looking statements may not be
realized due to a variety of factors, including, without limitation, (i) the
Company’s ability to manage the business despite continuing operating losses and
cash outflows; (ii) the Company’s ability to obtain sufficient capital or a
strategic business arrangement to fund its operations and expansion plans,
including meeting its financial obligations under various licensing and
other strategic arrangements and the successful commercialization of the
relevant technology; (iii) the Company’s ability to build the management and
human resources and infrastructure necessary to support the growth of the
business; (iv) competitive factors and developments beyond the
Company’s control; (v) scientific and medical developments beyond the
Company’s control; (vi) the Company’s inability to obtain appropriate
governmental licenses or any other adverse effect or limitations caused by
government regulation of the business; (vii) whether any of the Company’s
current or future patent applications result in issued patents and the Company’s
ability to obtain and maintain other rights to technology required or desirable
for the conduct of its business; (viii) whether any potential strategic benefits
of various licensing transactions will be realized and whether any potential
benefits from the acquisition of these new licensed technologies will be
realized; (ix) whether the Company can obtain the consents it may require to
sublicensing arrangements from technology licensors in connection with
technology development; (x) the Company’s ability to maintain its NYSE Amex
listing; and (xi) the other factors discussed in Item 1A, “Risk Factors”
contained in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2008 (the “Form 10-K”) and in other reports that we file with the
SEC.
Proposed
Merger; China Expansion
Additional
risks and uncertainties relate to (i) the Company’s proposed merger transaction
(“Merger”) pursuant to an Agreement and Plan of Merger with China
Biopharmaceuticals Holdings, Inc., a Delaware corporation ("CBH"), China
Biopharmaceuticals Corp., a British Virgin Islands corporation and wholly-owned
subsidiary of CBH, and CBH Acquisition LLC, a Delaware limited liability company
and wholly-owned subsidiary of NeoStem to acquire a 51% ownership interest in
Suzhou Erye Pharmaceuticals Company Ltd., a Sino-foreign joint venture with
limited liability organized under the laws of the People’s Republic of China;
and (ii) the Company’s other expansion activities in China, that may cause
actual future experience and results to differ materially from those discussed
in these forward-looking statements. Important factors (i) related to the
proposed Merger that might cause such a difference include, but are not limited
to, (a) costs related to the Merger; (b) failure of the Company's or CBH’s
stockholders to approve the Merger; (c) the Company's or CBH's inability to
satisfy the conditions of the Merger; (d) the Company's inability to maintain
its NYSE Amex listing; (e) the inability to integrate the Company’s and CBH's
businesses successfully and grow such merged businesses as anticipated; (f) the
need for outside financing to meet capital requirements; and (g) failure to have
an effective Joint Venture Agreement satisfactory to the parties and regulatory
authorities; (ii) related to the Company’s other initiatives in China that might
cause such a difference include, but are not limited to, (a) costs related to
funding these initiatives; (b) the successful application under Chinese law of
the variable interest entity structure to the Company’s business,
which structure the Company is relying on to conduct its business in China due
to the fact that the Catalogue Guiding Foreign Investment in Industries in China
categorizes the stem cell business as a prohibited business in China; (c) the
inability to integrate the Company and the business operations in China
successfully and grow such merged businesses as anticipated; and (d) the need
for outside financing to meet capital requirements; and (iii) related to each of
the Merger and the Company’s other expansion activities in China, respectively,
the other events and factors disclosed in the Company’s Current Reports on Form
8-K dated November 2, 2008 and July 2, 2009, respectively, relating to the
Merger and expansion into China, respectively, and other risk factors discussed
in Item 1A, “Risk Factors” contained in the Company’s Form 10-K and in other
periodic Company filings with the SEC and disclosed in the Proxy
Statement/Registration Statement on Form S-4 filed with the SEC in connection
with the Merger. The Company’s filings with the Securities and Exchange
Commission are available for review at www.sec.gov under “Search for Company
Filings.” Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. Except as
required by law, the Company undertakes no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.
GENERAL
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors which can then be accessed for their own future medical
treatment. We are managing a network of adult stem cell collection centers
in major metropolitan areas of the United States. We have also entered the
research and development arenas, through the acquisition of a worldwide
exclusive license to an early-stage technology to identify and isolate rare stem
cells from adult human bone marrow, called VSEL (very small embryonic-like) stem
cells. VSELs have many physical characteristics typically found in embryonic
stem cells, including the ability to differentiate into specialized cells found
in substantially all the different types of cells and tissue that make up the
body. Additionally, we are pursuing other technologies to advance our position
in the field of stem cell tissue regeneration.
The adult
stem cell industry is a field independent of embryonic stem cell research which
NeoStem believes is more likely to be burdened by regulatory, legal, ethical and
technical issues than adult stem cell research. Embryonic stem cell research is
also burdened with the issues of tissue compatibility. Medical
researchers, scientists, medical institutions, physicians, pharmaceutical
companies and biotechnology companies are currently developing therapies for the
treatment of disease using adult stem cells. As these adult stem cell
therapies obtain necessary regulatory approvals and become standard of care,
patients will need a service to collect, process and bank their stem cells.
NeoStem intends to provide this service.
Initial
participants in our collection center network have been single physician
practices who opened collection centers in California, Pennsylvania and Nevada.
Revenues generated by these early adopters have not been significant and are not
expected to become significant. However, these centers have served as a platform
for the development of NeoStem’s business model. Today NeoStem is focusing on
multi-physician and multi-specialty practices joining its network in major
metropolitan areas but continues to align with physicians that have a client
base who have indicated a particular interest in stem cell collection and
storage. Toward this end, NeoStem signed an agreement in June 2008
for a New York City stem cell collection center to be opened by Bruce Yaffe,
M.D., of Yaffe, Ruden and Associates, which facility became operational in
November 2008. In July 2008, NeoStem signed an agreement for a Santa Monica,
California based stem cell collection center to be opened by Stem Collect of
Santa Monica LLC at The Hall Center. This facility became operational
in the fall of 2008. Additionally, NeoStem signed an agreement with Celvida LLC
pursuant to which a Southern Florida stem cell collection center located in
Coral Gables, a suburb of Miami, became operational in September
2008. In March 2009, the Company signed an agreement to open a
collection center with the Giampapa Institute for Anti-Aging Medical Therapy in
Montclair, New Jersey. In addition, in May 2009 the Company entered into a
collection agreement with Primary Caring of Malibu in California.
During
2008, parallel to growing the platform business and the efforts we undertook in
that regard to establish a network of collection centers in certain major
metropolitan areas of the United States to drive growth, we recognized the need
to acquire a revenue generating business in the United States or abroad and
began exploring acquisition opportunities of revenue generating
businesses.
In
November 2008, NeoStem entered into the Merger Agreement with China
Biopharmaceuticals Holdings, Inc. (“CBH”) to acquire the 51% interest in Suzhou
Erye Pharmaceuticals Company Ltd. (“Erye”) a Sino-foreign limited liability
joint venture organized under the laws of the PRC, which has been in business
for more than 50 years and currently manufactures over 100 drugs on seven Good
Manufacturing Practices (GMP) lines, including small molecule drugs. Erye
specializes in research and development, production and sales of pharmaceutical
products, as well as chemicals used in pharmaceutical products. The Merger
Agreement was amended in July 2009. Also in November 2008, NeoStem
entered into the Share Exchange Agreement to obtain benefits from Shandong New
Medicine Research Institute of Integrated Traditional and Western Medicine
Limited Liability Company, a China limited liability
company. Subsequently, NeoStem decided to separately pursue its stem
cell initiatives in China and in July 2009 terminated the Share Exchange
Agreement and is in discussions with regard to acquiring an option to purchase
these operations during the next three years. Subject to the fulfillment of
various closing conditions (including stockholder approval), the Merger is
currently anticipated to close no later than the fourth quarter of
2009.
The
Company has begun other initiatives to expand its operations into China
including with respect to technology licensing, establishment of stem cell
processing and storage capabilities and research and clinical
development. RimAsia, a principal stockholder of the Company, has
been facilitating certain of these efforts and has paid certain expenses that
the Company has agreed to reimburse (approximately $473,000 of which was
reimbursed out of the proceeds of the private placement financing of preferred
stock and warrants in April 2009 which raised gross proceeds of $11 million,
described below). In connection with the expansion into China, the
Company has established the WFOE and put in place variable interest entity
arrangements with respect to each of Qingdao Niao and Beijing Research with
respect to these activities (described below). The Company believes
that these activities will be sufficient to help the Company expand into the
China market and shall be a substitute for its moving forward with closing the
transactions under the Share Exchange Agreement.
In
February and March 2009, in order to move forward certain research and
development activities, strategic relationships in various clinical and
therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, the Company issued promissory notes (the “RimAsia Notes”) totaling
$1,150,000 to RimAsia, which notes bore interest at a rate equal to 10% per
annum and mature on October 31, 2009 except that they matured earlier in the
case of an equity financing by the Company that raised in excess of
$10,000,000. The RimAsia Notes plus accrued interest were paid in April
2009 (as described below). Additionally, as of July 1, 2009, NeoStem,
CBH, CBC and RimAsia, which is a significant investor in the Company and CBH,
entered into a Funding Agreement pursuant to which it was agreed that RimAsia
shall supply additional funding to both NeoStem and CBH in an amount up to $1.6
million (including approximately $1 million advanced to date), which amount
shall be deemed settled upon its receipt of the increased amount of NeoStem
securities to be received by RimAsia as part of the Merger consideration as
agreed in the July amendment to the Merger Agreement. If less than
$1.6 million has been advanced at that time, the difference shall be paid to
NeoStem at the closing of the Merger. In the event the Merger has not
received shareholder approval by October 31, 2009, NeoStem is required to repay
RimAsia all payments incurred or made by RimAsia on behalf of
NeoStem.
The
Company has engaged in various capital raising activities to pursue its business
opportunities. In April and June of 2009, respectively, it raised
gross proceeds of approximately $11 million and $5 million, respectively,
through the private placement of its Series D Preferred Stock and Series D
Warrants.
The
acquisition of the VSEL technology was made through our acquisition of our
subsidiary Stem Cell Technologies, Inc. (“SCTI”) in a stock-for-stock
exchange. Although the funds obtained through the acquisition of SCTI
funded certain early obligations under NeoStem’s agreements relating to the VSEL
technology, substantial additional funds will be needed and additional research
and development capacity will be required to meet its development obligations
under the License Agreement and develop the VSEL
technology. NeoStem has applied for Small Business Innovation
Research (SBIR) grants and may also seek to obtain funds through applications
for other State and Federal grants, grants abroad, direct investments, strategic
arrangements as well as other funding sources to help offset all or a portion of
these costs.
During
the quarter ended March 31, 2009 the Company took steps to improve its
cryopreservation operations and reduce its fixed overhead by entering into a
four year agreement with Progenitor Cell Therapy LLC (“PCT”) to outsource
cryopreservation operations to PCT. Prior to commencing these services, PCT
agrees to provide certain preliminary services consisting of technology transfer
and protocol review and revision to ensure that the processing and storage
services are cGMP compliant. The agreement sets forth agreed upon
fees for the delivery of the services as well as providing for a one-time
payment of $35,000 for the preliminary services associated with the transfer of
the Company’s cryopreservation process and standard operating
practices to PCT’s laboratory and incorporation into PCT’s existing
standard operating practices. An initial payment of $20,000 was paid
upon commencement of services during the quarter ended March 31,
2009. The transfer of cryopreservation operations was completed in
April 2009, the final $15,000 was paid and the Company’s laboratory in Los
Angeles was closed in June 2009. The Company does not anticipate any significant
losses as a result of closing this laboratory. In addition, the Company believes
the shifting of our cryopreservation activities from a fixed cost to a variable
cost will allow the Company to utilize its cash in a more strategic
fashion.
In March
2009, the Company and PCT expanded PCT’s services to include its developing a
plan to set up a stem cell processing and manufacturing operation in Beijing,
China that the Company would pursue in partnership with an off-shore
entity. This plan would support research and cell therapy development
and manufacturing operations. The plan will include a conceptual
architectural design, cost estimates for construction, facility validation to
meet cGMP standards, equipment requirements and estimated costs of equipment
procurement, and other related matters. PCT’s fees for this work will
be $100,000 (of which $50,000 was paid in March 2009) plus
expenses.
In
connection with carrying out its expansion objectives in the PRC, NeoStem has
recently established a wholly foreign owned subsidiary in China, known as
NeoStem (China), Inc. (“WFOE”). The WFOE may engage in the research &
development, transfer and technological consultation service of bio-technology,
regenerative medical technology and anti-aging technology excluding the
development or application of human stem cell, gene diagnosis and treatment
technologies; consultation of economic information; import, export and
wholesaling of machinery and equipments (the import and export do not involve
the goods specifically stipulated in/by state-operated trade, import &
export quota license, export quota bidding, export permit, etc.). In
furtherance of complying with the PRC’s foreign investment prohibition on
stem cell research and development, clinical trials and related activities,
NeoStem’s current business in the PRC is conducted via two domestic variable
interest entities (“VIEs”): Qingdao Niao Bio-Technology Ltd. (“Qingdao Niao”)
and Beijing Ruijiao Bio-Technology Ltd. (“Beijing Ruijiao”), each a Chinese
domestic company controlled by the WFOE through various business
agreements.
To date,
the WFOE has been capitalized in the total amount of approximately $2,900,000.
The capital investment in the two VIEs is funded by NeoStem through the WFOE and
recorded as interest-free loans to the shareholders of Qingdao Niao and Beijing
Ruijiao. As of July 2, 2009, the total amount of interest free loans to these
shareholders of the VIEs listed as above was approximately $300,000. The Company
expects that the WFOE will require substantial additional funding in order for
the Company to continue its expansion plans in China associated with its stem
cell business.
In May
2009, Qingdao Niao entered into leases with Beijing Zhong-guan-cun Life Science
Park Development Corp., Ltd. pursuant to which Qingdao Niao is leasing
laboratory, office and storage space in Beijing for the aggregate monthly amount
of approximately $23,000. Lease payments are due quarterly in
advance, and upon entering into the lease a three month security deposit was
required in addition to the first quarterly payment. The term of the
leases is for approximately three years.
In June
2009, Qingdao Niao entered into a three year co-operation agreement with the
Qingdao Second Sanatorium of Jinan Military Command (“Second Sanatorium”). As
both a leading comprehensive hospital within the PLA network and as one of the
principal healthcare centers in charge of ensuring the well-being of senior and
retired military officials in China, Qingdao Second Sanatorium is a key player
within the domestic anti-aging and cosmetics arena. Qingdao Niao intends to
collaborate with Second Sanatorium to offer both stem cell based therapies for a
variety of conditions as well as stem cell based anti-aging and cosmetics
therapies.
In June
2009, Qingdao Niao entered into a co-operation agreement with Shandong Wendeng
Orthopedic Hospital (“Wendeng Hospital”) to conduct and develop clinical
research and the clinical application of autologous stem cells for the treatment
of a variety of orthopedic conditions for a term of five years. Wendeng Hospital
is considered to be one of the leading specialist orthopedic hospitals in China,
with close to 90% of their inpatient capacity dedicated to orthopedic cases.
Qingdao Niao intends to establish its first onshore patient treatment facility
in collaboration with Wendeng Hospital.
In July
2009, the WOFE entered into a cooperation agreement with NeoStem’s PRC
consultant, Shandong Life and Science Institute (“SLSI”), a not-for-profit
organization under PRC law, to organize and convene various clinical trials.
This agreement requires funding by the WOFE in the amount of RMB 5,000,000
(approximately $730,000).
In order
to advance our regenerative medicine business here and abroad, in February
2009, the Company entered into a License Agreement with Vincent Giampapa,
M.D., F.A.C.S pursuant to which the Company acquired a world-wide,
exclusive, royalty bearing, perpetual and irrevocable license, with the right to
sublicense, to certain innovative stem cell technology and applications for
cosmetic facial and body procedures and skin rejuvenation. In addition, in
January 2009, the Company and Dr. Giampapa entered into a three year consulting
agreement whereby Dr. Giampapa will provide consulting services in the
anti-aging area.
In order
to advance our regenerative medicine business abroad and expand our expertise
into a new area, effective March 2009, the Company entered into a
License Agreement with Regenerative Sciences, LLC (“RSI”), pursuant to which the
Company acquired an exclusive, royalty bearing, perpetual and irrevocable
license, with the right to sublicense, for the Asia territory, to use an
innovative process that rapidly grows a patient’s own adult stem cells to treat
a variety of musculoskeletal diseases. The licensed procedure
has been developed by RSI, a Colorado-based company focused on developing a
medical procedure for the treatment of chronic orthopedic
conditions. In addition, effective March 2009, the Company and RSI
entered into a three year consulting agreement whereby RSI will provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia.
In April
2009, the Company entered into a License Agreement with Vincent Falanga,
M.D., pursuant to which the Company acquired a world-wide, exclusive,
royalty bearing license, with the right to sublicense, to certain innovative
stem cell technology and applications for wound healing, continuing until the
later of ten years from the first commercial sale or the last to expire patent
claim.
In June
2009, the Company and Enhance BioMedical Holdings Limited ("Enhance
BioMedical"), a Shanghai corporation and a subsidiary of Enhance Holding
Corporation ("Enhance Holding"), entered into an agreement to develop a stem
cell collection and treatment network in Shanghai, Taiwan and the Chinese
provinces of Jiangsu, Zhejiang, Fujian, Anhui and Jiangxi using NeoStem’s
proprietary stem cell technologies. Enhance BioMedical has healthcare
provider relationships with numerous hospitals and doctors in Taiwan and
Shanghai, as well as in the five provinces in China to which the agreement
relates. Enhance BioMedical operates the Anti-Aging and Prevention
Medical Center in Taipei, Taiwan, with facilities focused on stem cell research
and development and anti-aging therapies. The agreement is a
ten-year, exclusive, royalty bearing agreement (which subject to certain terms
and conditions, is renewable for a subsequent ten (10) year term at the option
of Enhance BioMedical) pursuant to which the Company will provide Enhance
BioMedical with the training, technical, and other assistance required for
Enhance Biomedical to offer stem cell based therapies in Shanghai, Taiwan and
the five eastern China provinces. This agreement also gives NeoStem
the option to acquire up to a 20% fully diluted equity interest in Enhance for a
period of five years. NeoStem will receive certain milestone payments as well as
be entitled to a stated royalty on the revenues derived from Enhance
BioMedical’s offering these stem cell based therapies. In addition, NeoStem
may be eligible to receive other fees in connection with assisting in the
launching of the Network. Enhance BioMedical was an investor in the April 2009
Private Placement, pursuant to which it purchased $5 million of Series D Units,
and thus acquired 400,000 shares of Series D Stock (convertible into 4,000,000
shares of Common Stock upon stockholder approval) and 4,000,000 Series D
Warrants, each to purchase one share of Common Stock at an exercise price of
$2.50 per share (to become exercisable upon stockholder approval).
All of
the activities above are designed to broaden the scope of the Company’s
operations and to enter into the arena of advanced stem cell and regenerative
medicine therapies in the United States and China. While the Company continues
to pursue its platform business of operating a commercial autologous adult stem
cell bank, it has made a determination that the platform business will be
enhanced if the Company acquires and develops advanced stem cell regenerative
medicine therapies.
With
regard to the proposed Merger, it is not anticipated that in the next year this
acquisition will generate sufficient excess cash flow to support NeoStem’s
platform business and therefore NeoStem will also need to raise substantial
additional funds to fund its platform business and/or acquire another revenue
generating business. Additionally, even if the acquisition closes, the closing
will likely not occur until the fourth quarter of 2009 and NeoStem will need to
fund its platform business as well as the large costs associated with the
acquisition transactions until such time. NeoStem’s history of losses and
liquidity problems may make it difficult to raise additional funding. There can
be no assurance that NeoStem will be able to obtain additional funding on terms
acceptable to NeoStem. Any equity financing may be dilutive to stockholders and
debt financing, if available, may involve significant restrictive
covenants.
RESULTS
OF OPERATIONS
Three
and Six Months Ended June 30, 2009 compared to Three and Six Months Ended June
30, 2008
Revenue
For the
three months ended March 31, 2009, total revenues were $31,600 compared to
approximately $23,500 for the three months ended March 31, 2008. The
revenues generated in the three months ended June 30, 2009 were a combination of
milestone income of $6,300 earned on signing a licensing agreement with Enhance
BioMedical to develop a stem cell collection and treatment network,
which is being recognized over the contractual period of technology transfer;
$14,000 from stem cell collection fees and monthly stem cell storage fees,
$8,700 from fees derived from adding a new physician to our collection center
network and a prorata portion of fees billed our existing network physicians for
annual fees associated with their collection center agreements and $2,600 in
other revenue. The revenues generated in the three months ended June 30, 2008
were from stem cell collection fees and monthly stem cell storage fees in the
period in the amount of $8,500 and the balance of $15,000 were fees derived from
adding a new physician to our collection center network.
For the
six months ended June 30, 2009, total revenues were approximately $76,700
compared to $24,200 for the six months ended June 30, 2008. The
revenues generated in the six months ended June 30, 2009 were a combination of
milestone income of $6,300 earned on signing a licensing agreement with Enhance
BioMedical to develop a stem cell collection and treatment network, which is
being recognized over the contractual period of technology transfer; $58,600
from stem cell collection fees and monthly stem cell storage fees; $9,200 of
fees derived from adding a new physician to our collection center network and a
prorata portion of fees billed our existing network physicians for annual fees
associated with their collection center agreements and $2,600 in other revenue.
The revenues generated in the six months ended June 30, 2008 were from stem cell
collection fees and monthly stem cell storage fees in the period in the amount
of $13,200 and the balance of $15,000 were fees derived from adding a new
physician to our collection center network.
Operating
Expenses
Selling,
general, administrative and research expenses for the three months ended June
30, 2009 have increased by $2,335,800 or 98% over the three months ended June
30, 2008, from $2,379,400 to $4,715,200. During the last two years the Company
has used a variety of equity instruments to pay for services in an effort to
minimize its use of cash to incentivize staff, consultants and other service
providers. In the quarter ended June 30, 2009 the use of equity instruments to
pay for such expenses increased by $486,700 over the quarter ended June 30,
2008. These equity instruments were used to pay for staff compensation, director
fees, marketing activities, investor relations and other
activities.
Operating
expenses funded by cash were $3,145,900 for the three months ended June 30, 2009
compared with $1,296,700 in cash funded expenses for the three months ended June
30, 2008, an increase of $1,849,100, which was the result of:
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·
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The
activities related to our proposed merger with CBH have increased our
expenses by $392,400 primarily from the legal and professional services
utilized to prepare for public filings and shareholder approval of our
proposed merger.
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Our
efforts to establish an operation in China to provide processing and
storage as well as research and development capabilities and advanced
therapies has resulted in an increase in our operating expenses by
approximately $972,800 and included expenditures for rent of laboratory
space, legal expenses associated with establishing our subsidiary company
and related operations in China, consultants retained to support our
implementation and introduction of advanced therapies in China, recruiting
fees for identifying senior managers for our operation in China
and travel.
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Our
operating expenses in the United States increased $483,900.
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VSEL
Research in the United States has increased $284,400, in particular,
operations of our Boston research laboratory and related staff increased
operating expense by $209,800, fees paid to consultants to support our
research efforts have increased VSEL research expenses by $27,600,
payments to the University of Louisville in connection with our
obligations for the VSEL technology licensed in November 2007 increased
research expenses by $15,300, and patent expenses increased our
research expenses by $31,700.
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Administrative,
sales and marketing expense increased by approximately $199,500. Legal
expenses increased $44,800 and consulting fees increased $58,500 as the
result of the recently held annual shareholders meeting, licensing
agreements completed in the quarter and several filings with the SEC not
related to our Merger activities. Expenses related to preparing and filing
patents increased $17,500. Investor communications costs have
increased by $88,000 as the result of increased efforts to make investors
aware of the Company’s expansion into the development of stem cell
therapies and into China. Director fees increased $50,000 as the result of
a new Directors’ compensation plan introduced in April, 2009. The Company
completed its transfer of stem cell cryopreservation operations to
Progenitor Cell Therapy and closed its laboratory in June, 2009. The
transfer of cryopreservation operations increased expenses for the quarter
by $15,000. Surplus equipment was transferred to our Boston laboratory and
there were no other losses associated with the closure. The cost increases
were offset by decreases in salary and benefits of $35,800 as a result of
staff reductions the Company had been implementing in non-strategic areas
in the past year; these staff reductions have had a corresponding
reduction in travel expenses of $29,300. Accounting fees have decreased by
$26,600. In addition, marketing expenses have decreased by $28,800 as a
result of more focused efforts in major metropolitan areas. The balance of
changes in administrative, sales and marketing expenses have come
from a variety of areas that have resulted in a net increase of
$46,200 for the three months ended June 30, 2009 over the three months
ended June 30, 2008.
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Selling,
general administrative and research expenses for the six months ended June 30,
2009 have increased by $1,690,000 or 34% over the six months ended June 30,
2008, from $4,903,700 to $6,593,700. During the last two years the Company has
used a variety of equity instruments to pay for services in an effort to
minimize its use of cash to incentivize staff, consultants and other service
providers. In the six months ended June 30, 2009 the use of equity instruments
to pay for such expenses decreased by $606,700 from the six months ended June
30, 2008. These equity instruments were used to pay for staff compensation,
director fees, marketing activities, investor relations and other activities.
The reduction in operating expenses funded by using equity instruments was the
result of a general reduction in the use of such instruments in six months ended
June 30, 2009 versus the same period in 2008 and the fact that our 2003 Equity
Plan had a limited number of shares remaining for issuance.
Operating
expenses funded by cash were $4,792,200 for the six months ended June 30, 2009
compared with $2,494,600 in cash funded expenses for the six months ended June
30, 2008, an increase of $2,296,700, which was the result of:
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·
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The
activities related to our proposed merger with CBH have increased our
expenses by $677,000 primarily from the legal and professional services
utilized to prepare for public filings and shareholder approval of our
proposed merger.
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Our
efforts to establish an operation in China to provide processing and
storage as well as research and development capabilities and advanced
therapies has resulted in an increase in our operating expenses by
approximately $1,136,500 and included expenditures for rent of laboratory
space, legal expenses associated with establishing our subsidiary company
and related operations in China, consultants retained to support our
implementation and introduction of advanced therapies in China, recruiting
fees for identifying senior managers for our operation in China
and travel.
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Our
operating expenses in the United States increased $483,300.
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VSEL
Research in the United States has increased $405,900, in particular,
operations of our Boston research laboratory and related staff costs
increased operating expense by $256,900, fees paid to consultants to
support our research efforts have increased VSEL research expenses
by $23,500, payments to the University of Louisville in
connection with our obligations for the VSEL technology licensed in
November 2007 increased research expenses by $81,300, and patent expenses,
amortization of intangible assets as well as other related miscellaneous
costs combined to increase our research expenses by
$44,200.
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Administrative,
sales and marketing expense increased by approximately $77,400. Legal
expenses increased $63,100 and consulting fees increased $68,500 as the
result of the recently held annual shareholders meeting, licensing
agreements completed in the period and several filings with the SEC
not related to our Merger activities. Expenses related to preparing and
filing patents increased $17,500. Investor communications costs
have increased by $74,600 as the result of increased efforts to make
investors aware of the Company’s expansion into the development of stem
cell therapies and into China. Director fees increased $50,000 as the
result of a new Directors’ compensation plan introduced in April 2009. The
costs required to maintain our listing on NYSE Amex increased by $25,200.
The Company completed its transfer of stem cell cryopreservation
operations to Progenitor Cell Therapy and closed its laboratory in June
2009. The transfer of cryopreservation operations increased expenses for
the period by $35,000. Surplus equipment was transferred to our
Boston laboratory and there were no other losses associated with the
closure. These cost increases were offset by decreases in salary and
benefits of $131,900 as a result of staff reductions the Company had been
implementing in non-strategic areas in the past year, these staff
reductions have had a corresponding reduction in travel expense of
$83,900. Accounting fees have decreased by $24,800. In addition, the
marketing expenses have decreased by $113,100 as a result of more focused
efforts in major metropolitan areas. The balance of changes in
administrative, sales and marketing expenses have come from a
variety of areas that have resulted in a net increase of $97,200 for the
six months ended June 30, 2009 over the six months ended June 30,
2008.
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For the
three months ended June 30, 2009, interest income increased by $10,700 as the
result of investing the net proceeds of the April and June 2009 Private
Placements in money market funds. The Series D Preferred Stock requires an
annual dividend of 10%. This dividend is being recorded ratably each month and
resulted in a charge to operating results of $251,700 for the quarter ended June
30, 2009.
For the
six months ended June 30, 2009, interest income increased by $11,000 as the
result of investing the net proceeds of the April and June 2009 Private
Placements in money market funds. Interest expense increased by
$7,800 primarily due to interest paid on promissory notes issued to RimAsia in
February and March 2009 totaling $1,150,000. These notes were repaid in April
2009 upon the closing of the April 2009 Private Placement of Series D Preferred
Stock. The Series D Preferred Stock requires an annual dividend of 10%. This
dividend is being recorded ratably each month and resulted in a charge to
operating result of $251,700 for the six months ended June 30,
2009.
For the
reasons cited above, the net loss for the three months ended June 30, 2009
increased to $4,943,000 from $2,361,800 for the three months ended June 30, 2008
and the net loss for the six months ended June 30, 2009 increased to $6,810,300
from $4,889,000 for the six months ended June 30, 2008.
LIQUIDITY
AND CAPITAL RESOURCES
General
At June
30, 2009, the Company had working capital of $10,011,000. The Company
generates revenues from its adult stem cell collection activities, however, our
revenues generated from such activities have not been
significant. During the six months ended June 30, 2009, the Company
met its immediate cash requirements through existing cash balances, short-term
loans aggregating $1,150,000 and offerings of preferred stock and warrants
raising aggregate gross proceeds of approximately $15 million.
During
the first quarter of 2009, the Company issued promissory notes to RimAsia (the
“RimAsia Notes”), a principal stockholder of the Company, which aggregated
$1,150,000 (see Note 4 - Notes Payable). In April 2009, the Company completed a
private placement financing totaling $11 million (the “April 2009 Private
Placement”). The financing consisted of the issuance of 880,000 units
priced at $12.50 per unit (“Series D Units”), with each Series D Unit consisting
of one share of the Company’s Series D Convertible Redeemable Preferred Stock
(“Series D Stock”) and ten warrants (“Series D Warrants”) with each Series D
Warrant to purchase one share of Common Stock. A total of 880,000 Series D
Preferred shares and 8,800,000 warrants were issued. In June 2009 with a
final closing on July 6, 2009, the Company completed an additional private
placement financing with net proceeds of $4,679,220 (the “June 2009 Private
Placement”). This financing consisted of the issuance of 400,280
Series D Units priced at $12.50 per unit. A total of 400,280 Series D Preferred
Stock and 4,002,800 Series D Warrants were issued. The Company paid $324, 280 in
fees and issued 12,971 Series D Units to agents that facilitated the June 2009
Private Placement. The Series D Units issued to the selling agents
were comprised of 12,971 shares of Series D Stock and 129,712 Series D Warrants.
Upon the affirmative vote of holders of a majority of the voting power of the
Company’s Common Stock required pursuant to the Company’s Amended and Restated
By-Laws and the NYSE Amex, each share of Series D Stock will automatically be
converted into ten (10) shares of Common Stock at an initial conversion price of
$1.25 per share based on an original issue price of $12.50 per share; provided
that if by October 31, 2009 such affirmative vote is not achieved, the Company
must redeem all shares of Series D Stock at a redemption price per share of
$12.50 plus the accrued dividends as of such date. The total cash required to
redeem the Series D Stock is $16,165,638 plus accrued dividends. The
Series D Stock has an accruing dividend of ten percent (10%) per annum, payable
(i) annually in cash on April 9th. The Series D Warrants have a per share
exercise price equal to $2.50 and are callable by the Company if the Common
Stock trades at a price equal to a minimum of $3.50 for a specified period of
time. Subject to the affirmative vote of the Company’s stockholders and
the rules of the NYSE Amex, the Series D Warrants will become exercisable for
five years.
As a
result of NeoStem exploring acquisition opportunities of revenue generating
businesses, in November 2008 NeoStem entered into the Merger Agreement with CBH
(amended in July 2009) to acquire the 51% ownership interest in Erye, which
manufactures over 100 drugs on seven cGMP lines, and the Share Exchange
Agreement with respect to Shandong. The Company is also engaged
in other initiatives to expand its operations into China including with respect
to technology licensing, establishment of stem cell processing and storage
capacities and research and clinical development, which the Company decided to
pursue in lieu of consummating the transactions under the Share Exchange
Agreement. In June, 2009 the Company established NeoStem China as a wholly
foreign owned subsidiary of NeoStem. NeoStem China, a wholly foreign owned
entity, is domiciled in Qingdao and under its scope of business approved by the
Chinese regulatory authorities, the WFOE may engage in the research &
development, transfer and technological consultation service of bio-technology,
regenerative medical technology and anti-aging technology (excluding the
development or application of human stem cell, gene diagnosis and treatment
technologies); consultation of economic information; import, export and
wholesaling of machinery and equipments (the import and export do not involve
the goods specifically stipulated in/by state-operated trade, import &
export quota license, export quota bidding, export permit, etc.). In furtherance
of complying with PRC’s foreign investment prohibition on stem cell research and
development, clinical trials and related activities, we conduct our current
business in the PRC via two domestic variable interest entities. To date
operations in China have been limited. The Company has incurred and expects to
continue to incur substantial expenses in connection with these China
activities. The Merger transactions are not expected to close before
the fourth quarter of 2009 and in any event neither the Merger transactions nor
the Company’s other expansion activities into China are expected to generate
sufficient excess cash flow to support NeoStem’s platform business or its
initiatives in China in the near term.
As of
July 1, 2009, NeoStem, CBH, CBC and RimAsia, which is a significant investor in
the Company and CBH, entered into a Funding Agreement pursuant to which it was
agreed that RimAsia shall supply additional funding to both NeoStem and CBH in
an amount up to $1.6 million (including approximately $1 million advanced to
date), which amount shall be forgiven upon its receipt of the increased amount
of NeoStem securities to be received by RimAsia as part of the Merger
consideration as agreed in the July amendment to the Merger
Agreement. If less than $1.6 million has been advanced at that time,
the difference shall be paid to NeoStem at the closing of the
Merger. In the event the Merger has not received shareholder approval
by October 31, 2009, NeoStem is required to repay RimAsia all payments incurred
or made by RimAsia on behalf of NeoStem.
The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period indicated:
|
|
Six
Months Ended
|
|
|
|
June
30, 2009
|
|
|
June
30, 2008
|
|
Cash
used in operating activities
|
|
$ |
(5,221,200 |
) |
|
$ |
(2,698,100 |
) |
Cash
used in investing activities
|
|
$ |
(80,900 |
)
)) |
|
$ |
(2,400 |
) |
Cash
provided by financing activities
|
|
$ |
15,320,900 |
|
|
$ |
925,400 |
|
At June
30, 2009 the Company had a cash balance of $10,449,500, working capital of
$10,011,000 and stockholders’ equity of $3,794,800. The Company incurred a net
loss of $6,810,300 for the six months ended June 30, 2009. Our cash
used for operating activities in the six months ended June 30, 2009 totaled
$5,221,200, which is the sum of (i) our net loss, adjusted for non-cash expenses
totaling $1,818,600 which includes common stock, common stock options and common
stock purchase warrants issued for services rendered in the amount of $1,758,600
and depreciation and amortization of $60,000; (ii) an increase
in cash provided from unearned revenue from advanced payments from customers and
licensees of $112,600 and; (iii) cash used for payments of and
reductions in various accounts payable, notes payable, accrued
liabilities totaling $188,200 and cash used for other operating
activities such as prepaid insurance expense and accounts receivable totaling
$153,700.
The
Company relied on the RimAsia Notes issued to RimAsia for $1,150,000 and its
existing cash balances to meet its cash requirement for the three months ended
March 31, 2009. In April 2009, the Company completed a private placement
financing totaling $11 million which will be used to fund current
operations. Approximately $1,162,000 of such gross proceeds was
utilized to repay the RimAsia Notes plus accrued interest and approximately
$473,000 was utilized to reimburse RimAsia for certain costs advanced by RimAsia
in connection with the Company’s expansion activities into China. In June 2009
the Company completed a second private placement totaling $5 million which will
also be used to fund current operations. The Company believes that it
will need to raise additional capital to fund its expansion into advanced
technologies and therapies in the US and China including with respect to its
VSEL technology licensed from the University of Louisville and its other
regenerative technologies, including relating to anti-aging of skin, wound
healing and orthopedic applications. It currently intends to
accomplish this through additional financing activities, acquisitions of revenue
generating businesses and ultimately the growth of its revenue generating
activities in China. In addition the Company will seek grants for scientific and
clinical studies from the National Institutes of Health and other funding
agencies but there is no assurance that we will be successful in obtaining such
grants. It also anticipates that certain of its recent collaborative marketing
efforts will drive revenues particularly in its stem cell collection business.
The Company’s history of losses and liquidity problems may make it difficult to
raise additional funds. There can be no assurance that the Company will be
successful in obtaining additional funding on terms acceptable to the Company or
otherwise generating additional capital or revenue. Any equity financing may be
dilutive to stockholders and debt financing, if available, may involve
significant restrictive covenants.
SEASONALITY
NeoStem
does not believe that its operations are seasonal in nature.
OFF-BALANCE
SHEET ARRANGEMENTS
NeoStem
does not have any off-balance sheet arrangements.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
Not
applicable to smaller reporting companies.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Disclosure
controls and procedures are the Company’s controls and other procedures that are
designed to ensure that information required to be disclosed in the reports that
the Company files or submits under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) is recorded, processed, summarized and reported in
a complete, accurate and appropriate manner, within the time periods specified
in the Securities and Exchange Commission’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in the reports that the Company
files under the Exchange Act is accumulated and communicated to management,
including the Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required disclosure. As of the
end of the Company’s second fiscal quarter ended June 30, 2009 covered by this
report, the Company carried out an evaluation, with the participation of the
Company's management, including the Company's Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the Company's disclosure controls and
procedures pursuant to Rule 13a-15 of the Exchange Act. Based on that
evaluation, the Company's Chief Executive Officer and Chief Financial Officer
concluded that the Company's disclosure controls and procedures were effective,
at the reasonable assurance level, in ensuring that information required to be
disclosed by the Company in the reports that it files or submits under the
Securities Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the SEC's rules and forms and is accumulated and
communicated to management, including the Chief Executive Officer and Chief
Financial Officer, as appropriate to allow timely decisions regarding required
disclosure. Due to the inherent limitations of control systems,
not all misstatements may be detected. These inherent limitations include the
realities that judgments in decision-making can be faulty and the breakdowns can
occur because of a simple error or mistake. Additionally, controls can be
circumvented by the individual acts of some persons, by collusion of two or more
people, or by management override of the control. Our controls and procedures
can only provide reasonable, not absolute, assurance that the above objectives
have been met.
Changes
in Internal Controls Over Financial Reporting
There
have been no changes in the Company's internal controls over financial
reporting, as such term is defined in Exchange Act Rule 13a-15, that occurred
during the quarter ended June 30, 2009 that have materially affected, or are
reasonably likely to materially affect, the Company's internal control over
financial reporting.
NEOSTEM,
INC.
PART
II
OTHER
INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Previously
reported on the Company’s Annual Report on Form 10-K for the year ended December
31, 2008.
ITEM
1A. RISK FACTORS
Not
applicable to smaller reporting companies.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
Previously
reported on the Company’s Current Reports on Form 8-K dated April 13, 2009 and
June 29, 2009, and as follows:
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relation services to the Company since 2005, pursuant to
which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The issuance of such securities
was subject to the approval of the NYSE Amex, which approval was obtained in May
2009.
In
January 2009, the Company issued to its grant consultant 20,000 shares of
restricted Common Stock as a bonus under the consultant’s Consulting Agreement
with the Company dated February 8, 2008, in consideration for such consultant
being instrumental in securing the Company’s inclusion in the Department of
Defense Fiscal Year 2009 Appropriations Bill in the net amount of approximately
$680,000. The issuance of such securities was subject to the approval
of the NYSE Amex, which approval was obtained in January 2009. The
Company has entered into a new consulting agreement with such grant consultant
for a one-year term commencing as of January 1, 2009, pursuant to which it will
provide assistance to the Company in the following areas: (i) with
regard to negotiation, drafting and finalization of contracts; (ii) in the
development of strategic plans; (iii) with regard to funding from various
agencies of the State of New Jersey and Federal government; and (iv) with other
assignments it may receive from time to time. In consideration for
such services, the consultant will be issued shares of the Company’s restricted
Common Stock equal to a value of $60,000 based on the closing price of the
Company’s Common Stock on the date of execution of the agreement, which has been
determined to be 67,416 shares, to vest as to one-half of such shares on June
30, 2009 and the remaining one-half of such shares on December 31,
2009. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in May 2009.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock pursuant to the terms of a three month consulting
agreement entered into in October 2008, scheduled to vest pursuant to the
agreement as to 4,000 shares at the end of each 30 day period during the
term. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in January 2009.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of restricted Common Stock at a purchase price of $1.40
per share. This warrant was issued in consideration of services rendered after
the expiration of an October 2007 consulting agreement with the Company pursuant
to which this consultant was engaged to create marketing materials for our sales
and marketing staff. The issuance of this warrant was subject to the approval of
the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant which has been
providing financial market related services to the Company since 2008, pursuant
to which this consultant was retained to provide additional financial market
related services for a three month period. In partial consideration
for providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, to vest as
to one-third of the shares at the end of each monthly period during the term and
a five year warrant to purchase 25,000 shares of restricted Common Stock at a
per share exercise price of $1.00, vesting in its entirety at the end of the
term. The issuance of such securities was subject to the approval of the
NYSE Amex, which approval was obtained in May 2009.
On May 1,
2009, the Company entered into a three year consulting agreement effective March
3, 2009 (the “Effective Date”) whereby the consultant will provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia. Pursuant to this agreement, as
partial compensation for such services, the Company agreed to issue to this
consultant a warrant to purchase up to an aggregate of 24,000 shares of Common
Stock at an exercise price of $0.50 (the closing price of the Common Stock on
the Effective Date) which shall vest and become exercisable as to one-third of
such shares on each of the first, second and third anniversaries of the
Effective Date. The issuance of such securities is subject to the
approval of the NYSE Amex.
In April
2009, the Company entered into an agreement with a consultant to provide
financial market related services to the Company. In partial
consideration for providing services under this agreement, the Company agreed to
issue to the consultant an aggregate of 20,000 shares of Common Stock. The
issuance of such securities was subject to the approval of the NYSE Amex, which
approval was obtained in May 2009.
In April
2009, the Company entered into an agreement with a consultant to provide support
services in connection with our pending Merger to the Company. In
partial consideration for providing services under this agreement, the Company
agreed to issue to the consultant an aggregate of 10,000 shares of Common Stock.
The issuance of such securities was subject to the approval of the NYSE Amex,
which approval was obtained in May 2009.
The offer
and sale by the Company of the securities described above were made in reliance
upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended (the “Securities Act”), for transactions by
an issuer not involving a public offering. The offer and sale of such securities
were made without general solicitation or advertising to “accredited investors,”
as such term is defined in Rule 501(a) of Regulation D promulgated
under the Securities Act.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On May 8,
2009, the Company held its annual meeting of shareholders. Proxies
for the annual meeting were solicited pursuant to Regulation 14A under the
Securities Exchange Act of 1934. The items voted upon
were as follows:
|
1)
|
the
election of four directors (there was no solicitation in opposition to
management’s nominees as listed in the proxy statement, and all such
nominees were elected);
|
|
2)
|
the
approval of the 2009 Equity Compensation Plan, which makes up to 3,800,000
shares of Common Stock of the Company available for issuance to employees,
directors, consultants and advisors of the Company and its subsidiaries
pursuant to incentive or non-statutory stock options, restricted and
unrestricted stock awards, restricted stock units and stock appreciation
rights; and
|
|
3)
|
the
approval of the ratification of the appointment of Holtz Rubenstein
Reminick LLP as the Corporation’s independent certified public accountants
for the fiscal year ending December 31,
2009.
|
The
number of votes cast for and against the foregoing proposals (each of which was
approved) was as follows:
(i) The
election of Robin L. Smith, Joseph Zuckerman, Richard Berman, and Steven Myers
to serve as Directors of the Company until the next annual meeting of
stockholders. The votes cast were as follows:
Director
|
|
For
|
|
|
Authority Withheld
|
|
Robin
L. Smith
|
|
|
5,687,530
|
|
|
|
35,703
|
|
Joseph
Zuckerman
|
|
|
5,687,531
|
|
|
|
35,702
|
|
Richard
Berman
|
|
|
5,684,528
|
|
|
|
38,705
|
|
Steven
S. Myers
|
|
|
5,687,531
|
|
|
|
35,702
|
|
|
(ii)
|
Approval
of the 2009 Equity Plan. The votes cast were as
follows:
|
For
|
|
Against
|
|
|
Abstain
|
|
|
Not Voted
|
|
3,790,394
|
|
|
85,399
|
|
|
|
10,677
|
|
|
|
1,836,763
|
|
(iii) Approval
of the appointment of Holtz Rubenstein Reminick LLP as the Company’s independent
certified public accountants for the fiscal year ending December 31,
2009. The votes were cast as follows:
For
|
|
Against
|
|
|
Abstain
|
|
5,693,970
|
|
|
27,781
|
|
|
|
1,482
|
|
Effective
June 9, 2009, the Board of Directors of the Company approved the appointment of
Drew Bernstein as a director of the Company. Mr. Bernstein will serve as a
director until the Company's next annual meeting of shareholders. Mr. Bernstein
was also appointed as Chairman of the Audit Committee of the Board of
Directors.
ITEM
5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
(a) Exhibits
Exhibit
|
|
Description
|
|
Reference
|
|
|
|
|
|
2.1
|
|
Amendment
No. 1 to Agreement and Plan of Merger, made and entered into as of the 1st
day of July, 2009, by and among NeoStem, Inc., CBH Acquisition LLC, China
Biopharmaceuticals Holdings, Inc., and China Biopharmaceuticals Corp.
(1)
|
|
10.1
|
|
|
|
|
|
2.2
|
|
Notice
dated July 13, 2009 regarding termination of Share Exchange
Agreement*
|
|
2.2
|
|
|
|
|
|
4.1
|
|
Certificate
of Designations for Series D Preferred Stock (2)
|
|
4.1
|
|
|
|
|
|
4.2
|
|
Form
of Series D Warrant issued in connection with April and June 2009 private
placements (2)
|
|
4.2
|
|
|
|
|
|
4.3
|
|
Form
of Series D Subscription Agreement (2)
|
|
4.3
|
|
|
|
|
|
10(a)
|
|
Lease
Modification Agreement dated April 13, 2009 between NeoStem, Inc. and SLG
Graybar Sublease LLC and Original Agreement of Lease dated as of June 14,
2006, with related Consent and Assignment and Assumption Documents (3)
|
|
10.1
|
|
|
|
|
|
10(b)
|
|
Network
Agreement, dated June 15, 2009, between NeoStem, Inc. and Enhance
BioMedical Holdings Limited (3)(3a)
|
|
10.2
|
|
|
|
|
|
10(c)
|
|
Amendment
No. 1 dated June 29, 2009 to Lock Up and Voting Agreement (NeoStem) dated
November 2, 2008 by and between NeoStem, Inc., China BioPharmaceuticals
Holdings, Inc. and the individuals listed therein (3)
|
|
10.3
|
|
|
|
|
|
10(d)
|
|
Joinders
dated June 29, 2009 to Lock Up and Voting Agreement (NeoStem) dated
November 2, 2008 by and between NeoStem, Inc., China BioPharmaceuticals
Holdings, Inc. and the individuals listed therein. (3)
|
|
10.4
|
|
|
|
|
|
10(e)
|
|
Funding
Agreement made as of July 1, 2009 by and between NeoStem, Inc., China
Biopharmaceuticals Holdings, Inc., China Biopharmaceuticals Corp., and
RimAsia Capital Partners L.P. (1)
|
|
10.2
|
|
|
|
|
|
10(f)
|
|
Consigned
Management and Technology Service Agreement dated June 1, 2009 among
Qingdao Niao Bio-Technology Ltd., NeoStem (China), Inc. and The
Shareholder of Qingdao Niao Bio-Technology Ltd. (4)
|
|
10.1
|
|
|
|
|
|
10(g)
|
|
Equity
Pledge Agreement dated June 1, 2009 among Qingdao Niao Bio-Technology
Ltd., NeoStem (China), Inc. and The Shareholder of Qingdao Niao
Bio-Technology Ltd. (4)
|
|
10.2
|
|
|
|
|
|
10(h)
|
|
Exclusive
Purchase Option Agreement dated June 1, 2009 among Qingdao Niao
Bio-Technology Ltd., NeoStem (China), Inc. and The Shareholder of Qingdao
Niao Bio-Technology Ltd. (4)
|
|
10.3
|
|
|
|
|
|
10(i)
|
|
Loan
Agreement dated June 1, 2009 between NeoStem (China), Inc. and The
Shareholder of Qingdao Niao Bio-Technology Ltd. (4)
|
|
10.4
|
|
|
|
|
|
10(j)
|
|
Consigned
Management and Technology Service Agreement dated June 1, 2009 among
Beijing Ruijieao Bio-Technology Ltd., NeoStem (China), Inc. and The
Shareholder of Beijing Ruijieao Bio-Technology Ltd. (4)
|
|
10.5
|
10(k)
|
|
Equity
Pledge Agreement dated June 1, 2009 among Beijing Ruijieao Bio-Technology
Ltd., NeoStem (China), Inc. and The Shareholder of Beijing Ruijieao
Bio-Technology Ltd. (4)
|
|
10.6
|
|
|
|
|
|
10(l)
|
|
Exclusive
Purchase Option Agreement dated June 1, 2009 among Beijing Ruijieao
Bio-Technology Ltd., NeoStem (China), Inc. and The Shareholder of Beijing
Ruijieao Bio-Technology Ltd. (4)
|
|
10.7
|
|
|
|
|
|
10(m)
|
|
Loan
Agreement dated June 1, 2009 between NeoStem (China), Inc. and The
Shareholder of Beijing Ruijieao Bio-Technology Ltd. (4)
|
|
10.8
|
|
|
|
|
|
10(n)
|
|
NeoStem,
Inc. 2009 Equity Compensation Plan (5)
|
|
Appendix A
|
|
|
|
|
|
10(o)
|
|
Employment
Agreement dated July 6, 2009 between NeoStem, Inc. and Alan Harris, M.D.,
Ph.D. (6)
|
|
10.1
|
|
|
|
|
|
10(p)
|
|
Letter
Agreement dated July 8, 2009 between NeoStem, Inc. and Catherine M. Vaczy,
Esq. (6)
|
|
10.2
|
|
|
|
|
|
10(q)
|
|
Amendment
dated July 29, 2009 to Employment Agreement dated May 26, 2006 with Robin
Smith (7)
|
|
10.1
|
|
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
31.1
|
|
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
31.2
|
|
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.**
|
|
32.1
|
|
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.**
|
|
32.2
|
|
(1)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 1, 2009, which exhibit is incorporated
here by reference.
|
|
(2)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated April 13, 2009, which exhibit is incorporated
here by reference.
|
|
(3)
|
Filed
as an exhibit, numbered as indicated above, to the Registration Statement
on Form S-4 of the Company, Registration Number 333-160578, filed with the
SEC on July 15, 2009, which exhibit is incorporated here by
reference.
|
|
(3a)
|
Confidential
treatment has been requested for certain provisions of this Exhibit
pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended.
|
|
(4)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 2, 2009, which exhibit is incorporated
here by reference.
|
|
(5)
|
Filed
as an exhibit, numbered as indicated above, to the Proxy Statement of the
Company on Schedule 14A filed with the SEC on April 14, 2009, which
exhibit is incorporated here by reference.
|
|
(6)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 6, 2009, which exhibit is incorporated
here by reference.
|
|
(7)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 29, 2009, which exhibit is incorporated
here by reference.
|
|
|
*
Filed herewith
**
Furnished herewith
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
NEOSTEM,
INC. (Registrant)
|
|
|
|
|
By:
|
/s/ Robin Smith
M.D.
|
|
|
Robin
Smith M.D., Chief Executive Officer
|
|
|
|
|
Date:
August 13, 2009
|
|
By:
|
/s/ Larry A. May
|
|
|
Larry
A. May, Chief Financial Officer
|
|
|
|
|
Date:
August 13, 2009
|
Exhibit
31.1
CERTIFICATION
I, Robin
Smith, M.D., certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date:
August 13, 2009
/s/ Robin Smith, M.D.
|
|
Name:
Robin Smith, M.D.
|
|
Title:
Chief Executive Officer of NeoStem, Inc.
|
|
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
31.2
CERTIFICATION
I, Larry
A. May, certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date:
August 13, 2009
/s/ Larry A. May
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|
Name:
Larry A. May
|
|
Title:
Chief Financial Officer of NeoStem, Inc.
|
|
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of NeoStem, Inc. (the “Company”) on Form
10-Q for the period ended June 30, 2009 filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Robin Smith, M.D., Chief
Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: August
13, 2009
|
/s/ Robin Smith, M.D.
|
|
|
Robin
Smith, M.D.
|
|
|
Chief
Executive Officer
|
|
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of NeoStem, Inc. (the “Company”) on Form
10-Q for the period ended June 30, 2009 filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Larry A. May, Chief Financial
Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended ;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: August
13, 2009
|
/s/ Larry A. May
|
|
|
Larry
A. May
|
|
|
Chief
Financial Officer
|
|
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.